Pfizer

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.

Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.

hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84; Taken to ED; outcome unknown

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue

dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

Dizziness with first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Monitored vitals, which remained stable. Patient thought it was more of a mental effect because of something that a friend told her about the vaccine. Patient was reassured and when she felt better, was released back to work.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.

the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.

Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated. Vitals signs WNL, monitored for 60 minutes.

Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.

patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.

Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.

Patient complaint of dizziness. Vitals taken: BP 132/60, temp 97.3, heart rate 68, oxygen saturation 98%. Patient monitored for 30 minutes. Patient stated dizziness subsiding.

Patient received Pfizer vaccine at 1310. At 1340, she complained of dizziness. Vitals: B/P 132/60, temp 97.3, heart rate 68, oxygen saturation 98%. Patient alert and oriented. 1405 patient stated dizziness is subsiding.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's been vomiting. When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.

nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.

minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.

light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

The day after the vaccine when I woke up and tried to stand up I felt dizzy and couldn't stand on my feet because the spinning sensation, I had been like that for 3 days and recently decided to call to the doctor and the nurse told me to take some pills for the dizziness, on Friday I spoke with a doctor, I was on scale of 10/10 and now are on 2/10.

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential

About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.

Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on 28Jan2021at 09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation . Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined), and Prediabetes Concomitant medication(s) include takes medication for breast cancer and prediabetes. No other vaccines were given within 4 weeks No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is feeling better now. Patient checked her blood pressure and it was 127/72. The patient underwent lab tests and procedures which included blood glucose: High 146 on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021, cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown Information on the lot number has been requested.

Dizziness, Numbness of tongue and lightheadedness. 50mg PO Benadril. Monitored for 30 minutes. All symptoms resolved. No further intervention required. Patiient released to home with spouse.

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"

10 minutes after getting the shot I felt like I was going to pass out, I felt like my heart was beating slowly, I was breathing but felt like I couldn't get a good breath. It lasted about 5 minutes. I had the same reaction on methotrexate, which I quit taking.

Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.

Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.

Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

I developed vertigo a week after receiving vaccine. Had a second instance a week later. Vertigo developed again within a week after receiving second dose of vaccine and I had a second instance two days after the first .

Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about half an hour ago. She is brought over here by staff at the vaccine clinic. She continues to have some shakiness. She denies any pain or shortness of breath. Symptoms are worse when she is sitting up. She has had syncopal episode in the past. Denies any chest pain.

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it had gotten worse I would have gone to a hospital but it went away. Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.

Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.

Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.

After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained by EMS BP 177/106, HR 83, O2 sat 99%. Client stated she feels better. Client discharged home.

experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s

03/15/21 @3:30AM awoke with significant headache and vertigo, room spinning around me, could not lay flat. By about 7:00AM vertigo stopped, had HA, dizziness with loss of balance. Ibuprofen 400mg q3-4 hrs, sudafed 30mg q4 hrs. Continued unchanged x 48 hrs. Today, 03/17/21, HA, dizziness, loss of balance somewhat improved, still taking ibuprofen 400mg every 4-5 hrs . Had covid in January 2021 with HA and vertigo as presenting symptoms.

Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.

Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.

Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.

Week after receiving vaccine: Extreme bout of dizziness Aggravated existing tinnitus (left ear only) Appeared to be further hearing loss in left ear Sensations in face

After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Client c/o light headed feeling immediately after receiving vaccine. Client denies any other symptoms. Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%, Client verbalized a decrease in symptom and cleared to go home by EMT. Client advised to seek medical attention if symptoms worsened and she verbalized understanding.

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.

The injection was in the shoulder. Pain began less than one day later. I waited for the pain to resolve. It has not. My shoulder is still sore. The pain is getting progressively worse and it now hurts to comb my hair, it hurts to raise my arm to put dishes in the cabinet, and it is hard to carry lift and carry objects of 8 ounces more. This pain also make it difficult to sleep through the night.

She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time

patient states a few seconds after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.

Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.

Patient administered 1st dose Pfizer COVID 19 vaccination. Approximately 10 min after receiving vaccination, patient became dizzy and tremulous. Tremors increased for left arm to more generalized and more significant. Denied shortness of breath. ED and on site physician notified and patient transferred to ED for further treatment. .

Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...

dizziness, ear fullness after 10 minutes from getting vaccine. 125/79,76,98% drank some water and stated felt better, refused transport to ED

Potential hearing loss; Dizziness about one week after receiving which lasted about 3 hours; More intense tinnitus symptoms than usual; More intense tinnitus symptoms than usual; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9629), via an unspecified route of administration, administered in left arm on 08Mar2021 13:00 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Medical history included tinnitus, allergy to PCN and "Thygeson's Disease". Concomitant medication included ciclosporin (RESTASIS). The reported adverse events were dizziness about one week after receiving which lasted about 3 hours; more intense tinnitus symptoms than usual and potential hearing loss, all on 15Mar2021 at 17:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was recovering.

Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected

Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.

Patient received vaccine and in the waiting area after waiting for 6 minutes began to complain of lightheadedness. She stated that she has had a migraine for a few days. Patient's BP readings were 196/110, 195/107, 191/114. EMS was contacted and came to assess the patient. Her BP was 190/120 . She did not go to the hospital but was strongly advised to follow up with her doctor.

Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical advice if any further problems.

Patient stated she felt lightheaded. Vital signs taken and within normal range. Patient felt well after 17 minutes and left the facility.

3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.

History of orofacial granulomatosis, neurofibromatosis type 2, Sjogren's and trigeminal neuralgia. Around 10 minutes after reaching vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened

BP 100/100 mmHg, HR 72 History of Orofacial granulomatosis, neurofibromatosis type 2 and Sjogren's and trigeminal neuralgia Around 10 minutes after receiving the vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened.

Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP

Pt reported being sweaty, dizzy and fatigued about 5 minutes after receiving vaccine. Heart rate 80, BP 110/78 resp rate 22 SPO2 98%. Pt felt better within 15 minutes and was asking to go home. Was allowed to leave and advised if any further issues, she should go to ED

On Saturday, April 3, 2021 clientt received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 2:00pm. After vaccine was administered, client was to wait in the Observaton Area for 30 minutes due to Penicillin and sulfa drug allergy. At 2:09pm, client walked up to EMT and stated she was "feeling light-headed." Client was advised to sit in the anti-gravity chair and was given a bottle of water. Upon assessment by EMTs, client's last meal was at 12:30pm. Client also stated to EMTs she felt light-headed right after receiving the vaccine. At 2:13pm, the client stated the back of her neck felt "a little tight" and stated she had a headache. At 2:15pm vitals were taken: BP: 130/76, Hr: 57, RR: 15, O2 sat: 97%. Lead PHN was notified and advised client to be watched for an additional 30 minutes. Vitals at 2:20pm: BP: 128/78, HR: 59, O2 sat: 98%. Vitals at 2:25pm: BP: 128/70, HR: 59, O2 sat: 97%. At approximately 2:40pm, client stated her light-headedness and tightness on the back of her neck completely subsided. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client was able to ambulate with EMTs to her car with a steady gait at approximately 3pm.

Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Fainted morning after 2nd Pfizer shot and needed 8 staples for gash on back of my head. Second day after shot I woke up with 102 fever and general malice.

soreness extreme dizziness 4 days after with vomiting , unable to keep food down. headaches still vomiting second day with no fever but on and off chills

12:35PM STATES SHE IS LIGHT HEADED; FOREARMS RED - PLACED ON FLOOR WITH FEET ELEVATED.12:40 MOVED TO COT PER WHEELCHAIR. A/O, PINK, W/D, RESP REG WITH EASE. 12:48 'FEELS BETTER'. 1:50PM FEELS BETTER - HUSBAND HERE TO DRIVE PT HOME. NO REDNESS TO ARMS; NO ACUTE OR OBVIOUS DISTRESS NOTED.

Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being cold Reports tightness in throat - EMS activated

Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better early afternoon Late Afternoon April 4th: Dizzy, Nauseous, Light Headed, Collapsed and was unconscious for 2ish minutes - Called 911 -> Medics ran heart and bp tests which were all normal and did not consent to go to hospital Evening April 4th: Chills, Fever spiked to 100F, Nauseous, Light headed -Took 2 Tylenol pills - Did not take Ciprofloxacin evening dose Morning April 5th: Fever hovering around 100F, more color in face and up and moving around -Reported incident to doctor & pharmacist where Ciprofloxacin came from - Pharmacist contact information

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

1358 60 y/o female received 1st Covid vaccine and was sitting in observation room for 30 minutes. At the 30 minute mark pt stated that she felt dizzy when she tried to stand up. Brought Pt to backroom for evaluation she stated that her tongue felt thick and her lips felt numb. Vitals BP 136/75 P 74 Temp 99.3 . Pt was evaluated by Dr and he determined that she needed to be observed. 1412 Asked pt how she was feeling "Right eye feels funny like pressure and her throat was tight. At this time Dr determined that pt needed Epi Pen. 1413 Epi Pen administered to right thigh EMS was called. Vitals BP 174/86 P 75 R 22. Denied difficulty breathing. Pt became very emotional and stated she was scared. Reassured pt she was going to be fine and provided additional blankets for her chills. 1419 EMS took over her care

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

Thursday April 8, 8:15pm arm starts to ache; 8:30pm feel a little nauseous; 11:30pm feel dizzy (like the bed is moving under me) while I'm laying down. Friday April 9: 5:20am headache, body aches, nausea and fatigue; stayed in bed. 4:15pm went out to feed the cats and felt dizzy and kept loosing my balance; 5:30pm feel bad again: dizzy, headache and exhausted; That night my head ached and I felt mildly unwell. Saturday April 10: I feel better all around but I'm still getting dizzy and loosing my balance; also I still have a slight head ache. By 11:00 am, I'm feeling much better - just about normal.

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

Lightheadedness, BP 127/71, HR70, RR16. Patient stayed until felt better, laid down for 7 minutes and verbalized feeling better. Left in stable condition

I woke up Wednesday morning extremely dizzy and nauseous. I was unable to open my eyes because of how dizzy I was. I violently threw up for 2 hours . I was carried back to my bed by my husband. When I tried to roll over onto my side, I threw up again. I was unable to move on Wednesday. I actually thought that dying was easier. This sickness last 24 hrs. The next day I got out of bed around 11am and still suffered mild nausea. I am still a bit light headed today even when I woke up.

1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus 3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine 5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!

Patient was instructed to be monitored for 15 minutes after vaccine was administered. Patient stated she was feeling dizzy as she was entering her vehicle. She came back to see me at the consultation window approximately around 1:10p.m. I have her seated on a chair by consultation for close monitoring and informed her to let me know if she feels unwell. She stated she feels better after remained seated for another 15-20minutes.

Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still upset stomach and weakness today but getting better

Stiff and Severe lower back and left hip pain, unable to stand up without significant difficulty. I am a runner and since the injection, have barely been able to get out of bed or chair or to walk. Today is Sunday and have started being able to move somewhat,

Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.

Woke day after injection with dull headache as the day went on by 2pm I became extremely dizzy. The dizziness continued into the next day and then the third day as well. Woke the fourth day Thursday and dizziness was almost gone gone. By end of day no longer dizzy.

18 hours after receiving shot, experienced extreme sweating, chills, diarrhea, dizziness, passed out in my husbands arms. Husband shook me awake, applied cold compresses, and took two Ibuprofen tablets. Chills and sweating continued for several hours. The following day I was very weak and had a head ache. Next day was better.

4/6/21 headaches lasting days 4/8/21 sore throat 3 days 4/10/21 severe vomiting for 10 hours , dizzy, severe headache, body aches no fever 96.7°

Shortly after vaccination Patient complained of tingling, being lightheaded and then shortness of breath. Patient was evaluated by EMS, vitals stable and O2 sat was 98% on RA. After observation of 10 minutes, breathing became more labored and O2 sat decreased to 93%. Patient placed on a rebreather and given .5mg epinephrine. Patient was transported by EMS to Emergency Room for further assessment.

Feeling EXTREME dizziness and nausea that does not let up or subside. Unable to stand. feeling dizzy. Sudden whole body heating up. Face turns red. Symptoms do not get better.

Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.

102.9 degree fever off an on for about 18 hours after the first dose. Subsided by 9am the morning after the vaccine. Also, injection arm (non-dominant arm) incredibly sore to the point of not being able to raise it, but deep tissue massaging the site alleviated this symptom by 32 hours after vaccination. Filling this out for data collection purposes. Did not take any anti inflammatory or anti-fever medications to combat. Simply sweated out the fevers and drank lots of water.

Called 911, hospital dianosed with Vertigo. woke up in bed during night turned to right side and got dissy and nausus, happened twice called 911, hispital dianosed with vertigo , ct scan showed no clots in neck or brain, said could be iner ear, follow up with family doctor. was givenMeclizine 25 mg tablets, Ondansetron ODT 4mg tablets

Pt. developed a reaction to first dose #1 to COVID-19 vaccine. Symptoms: Pt. describes feeling dizziness. No hospital care provided. Pt. verbalizes feeling better and recovered. Pt. has allergies to codeine, morphine. Pt. declines V/S.

Pt calling to report a vaccine reaction to the 1st dose of covid vaccine. Pt describes about an hr after the shot she experienced dizziness, flushed face, tightness in throat, feeling of obstruction in her throat.

Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth

I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.

04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together

Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn, small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating. Subnormal temp all day. Burning feeling, sunburned skin continues as it comes and occasionally lessens.

I got extremely dizzy at 4:00am on Sunday after getting the shot about noon on Friday (so roughly 40 hours later.) The vertigo was so severe that I had to lay on my back and try no to move my head any direction. Getting up even to go to the bathroom resulted in nausea because of the intense dizziness. The dizziness/vertigo lasted until about 9:00am Monday morning (so nearly 30 hours.) I actually still have some residual dizziness when I move my head a certain way, but it goes away quickly and doesn't cause nausea. (I was worried I'd have a similar reaction to the second shot, but I only had some fatigue and a sore arm with the second shot.)

Lightheaded, dizziness, feeling warm developing after patient discharged from clinic prior to leaving facility, approximately 0825-0830. Returned to COVID vaccine clinic for assessment. Provided water, snack. Vs 0840: 163/86, HR 56, RR 18, 02 100%. States had not eaten this am, history of hypoglycemia. 0850: 160/75, HR 48-52, RR 18, 02 100%. States not feeling as warm but with increased dizziness. PT advised ER for further eval. Transferred to ER with staff.

experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.

1st IM Pfizer vaccination on 4-8-21, no issues until awakened at 4am on 4-13-21 with severe dizziness-room spinning, very mild nausea, still mild dizziness until midafternoon - no other issues until 4-18-21 at 5 am, once again awakened by severe dizziness, room spinning out of control- incapacitating dizziness continued well into next 12 hours of the day accompanied by severe nausea and headache, nausea improved with ondansetron and dizziness improved with meclizine after hours of not being able to ambulate.

This was my first shot. sore arm that hurts to move. 7am on 4/16 work up made cup of coffee, too exhausted to drink. Went back to sleep. Slept until 5pm. Eat soup, exhausted, fell back to sleep until 10pm. Talked on phone a bit, exhausted. Had chills, very hot feeling in head, ears, mouth when I was awake. Got body aches 10pm. I literally could not keep myself awake all day. Went back to sleep until 6am Saturday. arm still sore but a little better. Stayed awake all day. Still have hot feeling in head, ears, mouth. Dizziness. Fatigue, but better than Friday. Sunday, still the same as Saturday. I read people who get first shot side effects may have gotten covid and not known it. Oddly, On 1/3/21 I went to ER. Had pain in abdomen for days, winded walking in kitchen and out of breath when using stairs. Had high white blood on blood test. Was not tested for covid. If I had covid, that was probably it. It took a while to get better and I had the same hot feeling in head, ears, mouth like I do now. I hope I don't get worse reaction with 2nd shot

A 60 yo female was in the observation area following a 1st dose Pfizer (Lot# EW0171, expiration: 08/30/2021) that she received at 1215. At 1248 she flagged the Medic with a complaint of feeling lightheaded and a non-radiating headache rated 1/10 on pain scale. Client denied blurry vision, shortness of breath, nausea, vomiting, or chest pain. Client stated she has an allergy to aspirin and morphine sulfate, denied any past medical history and medications. Client states symptoms started 15 minutes post vaccine. At 1250 the medic took baseline vitals with client sitting: Blood pressure (BP): 110/80, Respiration rate (RR): 12, Heart rate (HR): 75, client was alert and oriented to time, space, situation and person (CAOx4) and skin was normal for ethnicity, warm and dry, pupils were equal, reactive to light and accommodating (PEARL). Client stated headache increased to 3/10 and continued to deny any other symptoms. Client stated last oral intake was at 0900 and claimed minimal fluid intake. Client was offered a bottle of water. At 1301 second set of vitals taken with client standing: BP 112/80, HR 72, RR, 12, CAOx4, negative for orthostatic pressures. Client stated the lightheadedness was gone and headache remained at a 3/10, client attributed headache to lack of fluid intake. At 1315 client released from observation area. Client was able to stand and walk without assistance and left the observation site with a steady gait.

Shot 1: Site soreness (severe) lasting 1 week, fever, chills, headache, tiredness 48 hours. Shot 2: Site soreness (not as bad as shot 1) for 1 week. 48 hours tiredness, headache, chills, fever. Next 48 hours: tired, headache. One week later starting experiencing dizziness, fatigue, tinnitus. Continuing off and on one month after 2nd vaccine. Have a good then several bad days. Seems to be getting worse and more chronic. Wake up tired but not dizzy and within 45 minutes dizziness starts up and continues through until late afternoon. Fatigue is chronic and fairly bad no matter how much sleep I get. Tinnitus (which I have never had before) is consistent but not super severe. Never had dizzy spells or vertigo before either.

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.

Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.

Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.

patient experienced blurry vision approximately 15 minutes after receiving vaccine and the blurry vision lasted 10 mins. She also reported experiencing a headache on the left side which also last 5min. She indicated feeling dizzy for a few minutes. Recovered completely by 3:15 Ppm

Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner

Felt burning sensation in left pinky finger while driving on hwy. then numbness in both hands and legs . Then going to a shock not feeling my body and weakness in jaw and loss of motor skills, like paralysis, not able to walk or speak. Loss of speech for about 90 minutes.

I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.

DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION

The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.

My shoulder joint began to hurt about four hours after my vaccination. I couldn't raise my left arm. My shoulder felt stiff and like it was out of joint. It was extremely painful to move it and I couldn't raise my left arm, I thought maybe the injection had been given too high on my arm and caused SIRVA

Patient with PMH type 2 DM, cataracts and dry eyes and allergy to penicillin (anaphylaxis) recevied Pfizer Covid19 vaccine at 1529 3/31/21 (lot #ER8733) in left deltoid. No known sequela after first shot. Patient received her second dose of Pfizer vaccine (lot #EW0162) in her left deltoid on 4/21/21 at 1556. During initial observation period, she felt dizzy. At 1614, she felt tingling in her throat and tongue. VSS and no other symptoms. Patient was given juice and monitored x10 additional minutes without resolution of symptoms. Provider was made aware and assessed the patient. 25 mg IM diphenhydramine was given via right deltoid. Patient monitored an additional 30 minutes and symptoms resolved.

Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

Pt became dizzy, diaphoretic and felt like passing out approx 10 minutes after receiving the vaccine. Upon arrival to med obs area, pt was alert. BP 97/68, HR 76, O2 95%. Pt rested on gurney and felt better shortly after having water and crackers. recheck BP 109/72, O2 94%. Pt stayed in observation until 1300, with last check of BP 112/67, HR 76 and O2 97% while standing. Pt felt comfortable being released. She was discharged with her daughter in her own wheelchair.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.

Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.

Within an hour, dizziness. That night, fatigue, pain in arm, bad,bad headache, neck ache. Fever around 100 degrees. Morning after, bad headache, fever over 100 but less than 101. Within 24 hours, headache, shoulder, back, neck ache. Fever with Tylenol 101.6. Sore throat. Possible swollen glands. Waiting to see if better at 48 hrs.

60 y/o female, with past medical history HTN, anxiety, high cholesterol, and artery stenosis seen today for report of feeling lightheaded, hot flashes, tremors and the feeling of something cold running through her legs going to her stomach about 5 minutes post vaccination. Patient also reports that she took her medications this morning. (amlodipine 5 mg, HCTZ 12.5 mg, Atorvastatin 40 mg, metoprolol ER 100 mg, and escitalopram 10 mg. Patient states that this is her second dose in the series. NP and Paramedics at patient side. Patient is hypertensive despite taking all blood pressure medications. B/P 184/88, HR 78, 99% RA, 19 Resp, bs 108). Bottle of water provided to patient and her legs were elevated on a chair. Repeat BP obtained. Patient BP decreased to 187/82. Patient blood pressure is still elevating 152/76 and still complains of coldness feeling that moves to her abdomen. Patient advise to go the hospital. Patient and her husband agree to go the hospital. Patient transferred to the hospital accompanied by her husband.

Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

woke up on the 22nd with vertigo that affected me lying sitting or standing. this vertigo got progressively worse until the 28th when i called my doctor. he directed me to take meclizine 25mg, 3x day, and that if it wasn't better to call in 7 days, or if it got worse to call right away. *i have left-side hemiparesis from cva (2016). the 1st shot was in bad arm, and had no vertigo, but i did have extreme sleepiness for two weeks. this was not separately reported. this 2nd shot was in good arm, and i am not tired at all.

Fear of needles, lightheaded. BPs 149/91 (pulse 74), 138/89 (pulse 73). O2 sats 98%-100%. Given juice, water, and crackers.

1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.

pt said her arm hurt immediately after taking the vax and she experienced strange pains in random spots. She got home and was very dizzy. She was stiff and achy. Today she woke up feeling wiped out, very fatigued. She has a slight fever, chills and pains. She has taken 2 Bayer aspirin.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Vertigo, ongoing since 04/25/21 and continuing today. Severity has lessened, but I still experience it a few times daily.

I awoke on April 5th at 6 am. I was deaf in both ears except the sound of my own saliva in the right ear. Upon attempting to rise I was exceedingly dizzy/light-headed. I went to the ground and then extreme loud - extremely loud sound in head. I held my head in my hands and attempted to stand again and could not. Finally I was able to stand and get myself to the bathroom. The loud sound and deafness continued for about 20 to 30 minutes at that intensity, then lessened. Was back to "normal" about an hour later, except fullness in right ear. I really should have called 911, yet I was in a rural area with my 99 year old mother and did not want to startle her. One week later, April 13th, tinnitus, lower volume, and vertigo returned. Vertigo was intermittent; tinnitus has been 24/7 since April 13th. I saw ENT, on April 7th. He thought I either had a stroke or a vestibular migraine, yet he was not aware of the 24/7 tinnitus. He ordered MRI. Results negative for stroke or tumor. I have an appointment with ENT next week. (Was visiting my mom and family at time of initial acute onset.)

This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trigeminal neuralgia attack; massive vertigo attack; eye was so swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included trigeminal neuralgia, head injury, pulmonary problems, severe migraine and tumor in lymph node. Concomitant medications were not reported. On 09Apr2021, the patient lost consciousness; in Apr2021, she experienced trigeminal neuralgia attack, massive vertigo attack and eye was so swollen; on an unspecified date she experienced also sickness and couldn't eat anything down. The patient specified that right after she got the injection, they make you to sit there for 15 minutes to see. She lost consciousness, it was like they gave her a shot before you go on for surgery and the doctor had come over, they had to wake her up. She didn't know what happened, so that was the first thing and the doctor said that's out of all the 1000's of people they vaccinated she was the first one that passed out right after the injection. So, she thought may be that should be noted somewhere and she didn't get a headache that she has a condition called Trigeminal neuralgia which was extremely painful and it's like only 3% of the population get it and it's usually caused after major head injury, was the very next day her shot was on the Friday and then Saturday the pain was terrific and she had the trigeminal pain for a week, took a week to go away and then right after that the next week she had a massive vertigo attack. And she really didn't know all these things or side effects from her head injury. But her conditions are pretty rare, you only get them if you've got massive concussions and fractured skull and stuff like that which happened a long time ago. So she didn't know if the shot had anything to do with it. She has pulmonary problems so she was getting it no matter what because she can't go anywhere hery Pulmonologist won't let her leave the house unless she has to go to a doctor or an emergency room. And she did go to the emergency room because her pain medication wasn't working at all (Unspecified medication). She used to have migraine but after the head injury the migraine went away which she was very happy because she had severe migraine. What she didn't know was this Trigeminal neuralgia the nerve pain. The consumer further specified that she was so happy with the vaccine and she mean she doesn't care what the normal side effects are, she didn't have any other side effects her arm never hurts, she never had any fatigue or headache but she didn't know it was odd, the very morning she woke up Saturday she was in excruciating pain, its nerve pain that went down to the jaw, right under her eye and over the forehead and it's the most extremely painful thing that people get. She takes medication (Unspecified medication) daily to try to control it but sometime the pain is really really bad. She had been sick for the 3 weeks, she did not think anything had to do with the vaccine except the trigeminal. But it could have caused a massive vertigo attack which lasted 8 or 9 days. Today was the first day she was eating food in a week because she couldn't eat anything down. The patient was on a lot of steroids, she was reducing but she was still very plump so she thinks it's about 270 pounds right now. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.

Joints are very painful. My shoulders hurt and rec cortisone shot and doing pt. My knees I was hoping it would go away but m y knees are very sore. They started hurting the night after the shot. I could barely walk. That night. They started to get somewhat better with rest and Wishing it would go away but it is not. So I have an apt for my knees now This is crazy. I use to walk everyday for 3-4 miles and I can?t barely make it to a car or down the steps.

With the 1st shot arms got heavy; Couldn't move arms for about 4 min; The next 2 days I felt like an oven door was opened inside me. Very hot inside but outside body was cool; This is a spontaneous report from a contactable 60-year-old female (Nurse). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot no: EL1283) via intramuscular administration, administrated in right arm on 12Jan2021 11:15 AM, as single dose and second dose (Batch/Lot no: EL3302) via other route administrated in right arm on 02Feb2021 12:15 PM as single dose for COVID-19 immunization. The patient medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. The patient concomitant medications included Simvastatin 40mg, Duloxetine 30-60mg, Raloxifene 60mg, Chlorthalidone 25mg, Levothyroxine 0.88mcg, Calcium 600mg with 500IU Vitamin D, Folic Acid 400mcg, Fish Oil 1400mcg, B12 5000mcg, Vitamin D 2000IU and Tumeric 1000mg. The patient had second dose on 02Feb2021. After the first dose patient experienced patient arms got heavy and then pateint couldn't move them for about 4 min. The next 2 days patient felt like an oven door was opened inside. Very hot inside but outside body was cool, no redness or sweating. patient 2nd shot on arms didn't get heavy, just felt a weakness going from shoulders down to hands. Couldn't move or feel them for 15 min. Slowly patient could move fingers then hands then lift arms. The next day patient brain felt kind of fuzzy. Still a little "off kilter" on 2nd day. Patient did not have any anxiety about either shot, even with what happened with the first one. (patient the one reporting - it says patient from a healthcare professional reporting for a patient and patient couldn't change it). Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136873 Same patient, same drug, different vaccine date

Atrial fibrillation started, one hour after vaccine. Rushed to ER, Electrical Cardioversion given Experienced Vertigo, 18 hours after vaccine.

I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown. Information about batch/lot number was available. Further information was expected.

Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.

It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.

allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood up and became so dizzy I feel head-first into a chair next to the place I was standing. Since that time I have experienced extreme vertigo (for the first time in my entire life I have never been dizzy in my life, at all). I can?t lay on my left side because I can?t turn my head to the left. I can?t drive because I can?t turn my head to the left. When I do, my head becomes swimmingly dizzy. It is an extreme dizziness. Not just lightheaded. Also I cannot lean my head backward to look up because I experience the same thing. I have joined a website for COVID-19 Vertigo side effects in order to get information or ideas as to what I can do and when I can hope for relief.

The symptoms began at about 8 PM on 1/28/2021. I was very congested. I had a stopped up nose. When I woke up on 1/29, I was really dizzy and had a sore throat, and my nose was still stopped up. I decided not to go to work. I went to the doctor to get it checked. The doctor asked a lot of questions and said that it was an allergy. They gave me a prescription for Zyzal. They concluded it was seasonal rhinitis due to pollen.

Released from ER after receiving 2nd Pfizer vaccine. 1 mile down the road, I could no longer drive. I had to pull over on the highway. I had a tingling in my face, immediately followed by a combination of severe headache, hard to breath, rapid heartbeat and feeling like I was going to pass out. I wasn't able to even dial my phone. A construction worker on the side of the highway called for the ambulance and I was transported back to the ER.

This vaccine triggered my meniere?s. It has proceeded to to get worse. I have been dizzy now for 4 weeks along with a headache and nausea. It is very debilitating and cannot continue to cope this way. I need to get back to a normal life.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered. No follow-up attempts are possible. No further information is expected.

60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was alert and tracking with her eyes while nervous. Client had a chief complaint of anxiety post vaccination. Client stated she began to feel anxious shortly after her vaccination and requested to lie down for the duration of her observation. Client has a history of anxiety for which she is taking CBD oil. Client also has a history of new onset tachycardia and periodic irregular heart rate for which she sees a cardiologist. Client was recently diagnosed with transient amnesia. She denies any allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing, and circulation were intact. Client denied any pain throughout her body. Client's initial vitals were a heart rate of 76 and irregular, blood pressure 160/98, respirations 20 and regular, alert and oriented to person, place, date and event, eyes equal and reactive to light, lung sounds clear bilaterally and SPO2 100% on room air. Client was shaking while anxious but consolable. Client consented to an additional 30-minute observation after her first set of vitals. She was provided water during her observation. Her remaining vitals at 1152 - 158/98, pulse 86, O2 99% respirations 16. After approximately 5 minutes, client reported that she felt much "better" and remained calm for the rest of her observation. Client's vitals improved at the completion of her observation with a heart rate of 80 and regular, respirations 16, blood pressure 140/88 and O2 98%.. Client departed vaccination site after 30mins of observation feeling "better".

2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.

A little light headed; very tired; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 at 60-years-old (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included High blood pressure. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Patient had no known allergies. Facility type vaccine: Other. Concomitant medications included amlodipine besilate (NORVASC). The patient experienced a little light headed and very tired on 10Mar2021 14:00 with outcome of recovered in Mar2021. No treatment received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.

feeling a bit woozy; weak; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 at 10:45 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included asthma and arthritis. The patient had known allergies to sulpha drugs, keflex, levoquin, and codeine. Concomitant medications included desloratadine (CLARINEX [DESLORATADINE]), montelukast sodium (SINGULAIR), lansoprazole (LANSOPRAZOLE), diltiazem (DILTIAZEM), and estradiol (ESTROGEN). The patient received no other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021 at 11:00 reportedly, the patient started feeling a bit woozy and weak about 5 min after the shot and that feeling continued 2 hours later. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.

After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 12:00AM, I had headaches, muscle pain, shortness of breath, cough, muscle pain, weakness, dizzy. Sleeping until 1:00pm on 6/9. The body temperature was down to 37.8C?but still dizzy and no energy at all. I feel better today, and body temperature has down to 37.4, and the shortness of breath is getting better, but not as normal, and had cough sometimes, but not too bad.

Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and dizzy. We laid her down flat on the floor with a pillow and got her some water. We checked her blood pressure, and it was approximately 90/58. Patient says her BP usually runs very low. She stated she had just been for a 4 mile run in 90+ degree heat, had not eaten much that morning, and had not drank much water. After about 20 minutes, she began vomiting. After about 40 minutes from time of vaccine, her son picked her up and took her to a nearby ER at her request. I called her the following day, and she had recovered.

significant aches; pain in her hips after the first dose/ Joint pain; after the first vaccine, she couldn't stand up straight, she was walking like a monkey; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included covid-19 from 21Dec2020 to 11Jan2021, lower back pain (had lower back problem for years), herniated L2 and L3 from 2015, had sciatica on left, but sciatica was lower back and down leg (never joints and hips). The patient's concomitant medications were none. The patient previously received hep B shots (HEPATITIS B VACCINE) for Immunization (had Hep B shots, all vaccines as a child) and flu shots (INFLUENZA VACCINE) for Immunization (flu shots every year and had the herpes). Patient did not have any history of all previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Patient did not have family medical history relevant to adverse events. On an unknown date in 2021, patient experienced significant aches, pain in her hips after the first dose, after the first vaccine. It was also reported, she couldn't stand up straight and was walking like a monkey. The patient experienced joint pain. Her doctor didn't believe that it gave her joint pain. She got a new doctor and told him about the right side which she never had any problems before. He said, "maybe you are overcompensating". The patient had lower back problem for years. It was good to hear that it can cause joint problems. Her doctors did not believe her. Doctor gave her tramadol which takes the pain away for 1 day but that was it. Further stated, received both doses of the Pfizer covid vaccine. Since receiving the Pfizer covid vaccine, had significant aches and pains in joints. The aches and pains began after the first dose of the covid vaccine. The first dose was not so bad, she felt like maybe it was from the rain. This all started the next day after her first dose, she went to work and it was raining bad, and she told the secretary her hip joints were hurting and she cannot stand up straight but she thought it was the rain and she had turned 60, she thought she would just had joint problems, but she had no problems until the day after the first vaccine, she could not stand up straight, she was walking like a monkey. Everything seemed to be fine, it was easing up. The patient went to Doctor for the first time, he gave her Tramadol, too, and it took away the pain for one day. She had a herniated L2 and L3, she was unsure which was torn. This was diagnosed in 2015, she's been going to Pain management since at least 2017. She never had joint pain in hips ever, especially on the right side, she always had sciatica on left, but sciatica was lower back and down leg, never joints and hips. She had Hep B shots, all vaccines as a child, even had flu shots every year and had the herpes, or whatever one if you had chicken pox as a kid, now you'll get it, she had that as a series, 2 or 3 shots, and had no side effects. The patient used to go to gymnastics when she was little and has two herniated discs and a tear in the back, which was why she goes to pain management. Clarifies she had a herniated L2 and L3, she was unsure which was torn. This was diagnosed in 2015, she was been going to Pain management since at least 2017, but never for hip/joint pain and swelling, like since the COVID vaccine, and also, she had COVID in December and January, maybe she shouldn't have got it, she was hearing the antibodies were good for a year, maybe it was too much on top of her having COVID. She was intelligent and was thinking perhaps she gave herself too much dose, she already had antibodies, the doctors said to get vaccinated even though she had COVID, they did not know how long the antibodies last, they said maybe 3 months, but she got the COVID vaccine within the three-month time, so she was unsure if that was the reason why this happened. There was no investigation assessment and Relevant tests. The patient not visited emergency room and physician office due to the events. Therapeutic measures were taken as a result of significant aches, pain in her hips after the first dose. The outcome of event ache and pain in hip was not recovered while unknown for other.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021642671 Same reporter/ drug,different patient

had soreness in my left arm where the vaccine was administered; she felt a little more soreness; feeling lethargic; experienced dizziness, weakness and tiredness; experienced dizziness, weakness and tiredness; experienced dizziness, weakness and tiredness; This is a spontaneous report from a contactable consumer. This 60 (and a half)-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 (at the age of 60 (and a half)-year-old) as 1st dose, single for COVID-19 immunization. The patient's medical history included blood pressure. The concomitant medications included unspecified basic blood pressure medication (no further details provided). No prior vaccination was taken within 4 weeks. The patient stated that her last vaccine she got as child. The patient believed she took her blood pressure medication that morning and that she wasn't told not to take anything. It was reported that on 05Jun2021, within 15 minutes after getting the vaccine the patient started to feel the dizziness. It wasn't severe. She felt a little week from it and those didn't start until probably 30 minutes after the injection and lasted for about 1 hour. The patient did not eat that morning. She did get up and before she left and she grabbed something to eat and drink (had a fruit smoothie). The patient took a car service there. The patient still felt it but not to a great degree. The patient reported that she sat there at the site for about 15-20 minutes and as she went to get up and started walking toward the door, she did feel slightly dizzy. The patient was asking if this was common or not. She stated it was not really dizzy, like faint dizzy, but she felt dizzy and weak. She stated that about 2 hours after the vaccine she felt tiredness and that lasted most of the afternoon for a good couple of hours and nothing else. The patient kept moving and pushing and stopped within a half hour after she got home and in the next hour, she started to feel tired. She was moving around getting things done (she was doing renovations at her house) and hour and half she got home she started to feel a little tired and sat down. In the evening hours she was feeling ok, not feeling as tired, feeling lethargic. It just lasted that Saturday. The patient stated weakness wasn't as bad as the feeling tired. On 06Jun2021, Sunday morning the patient had soreness in her left arm where the vaccine was administered. Most of the day she felt soreness no dizziness and not feeling tired. Today she was feeling fine and back to normal. Maybe a little tenderness at the site. The patient considered dizziness and weakness as severe allergic reaction and not just a side effect. The patient did not have emergency room visit or physician office visit for events. The patient came across the report. Her daughter and her husband got the Moderna: they had no side effects, and they were younger than the patient. The patient had scheduled her second dose on 26Jun2021, and she was wondering if what she experienced with the 1st dose is it possible to experience it to a greater degree with the 2nd dose. The patient reported that she was seen by her primary care for a complete physical before and did consult with her to discuss having the vaccine administered and she got the go ahead. The outcome of the event "feeling lethargic" was reported as resolved on 05Jun2021. The outcome of the events "experienced dizziness, weakness and tiredness", "had soreness in my left arm where the vaccine was administered", and "she felt a little more soreness" was reported as resolved on 07Jun2021. Information about lot/batch number has been requested.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment. chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or not. was difficult to eat due to the pain. didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes. longterm outcomes unkn.

Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA

patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.

Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.

As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.

trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.

Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4 hours.. they checked my vital and sent me home after everything was clear .

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic

On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them- as the day progressed I had to use a walker & by late afternoon a wheelchair. The pain in my knees was a 10 out of 10.

At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.

Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.

not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown. The following information on the batch/lot number has been requested.

No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.

Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts below the left AC and extends up to the acromion process. Intermittent relief when taking OTC pain medications.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.

Pain in shoulder joint starting the morning after I received my first dose. Continued till date of my second dose and got worse after 2nd dose given in same arm due to medical recommendation for better vaccine response. Have pain on lifting arm. Can?t raise it more than 75 degrees without great pain. Trouble pulling or pushing with that arm or carrying heavy things. Have not had issues with this arm before vaccination.

Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.

Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.

Received second dose of vaccine and had minor symptoms X approximately 1 day. On day 10 after 2nd dose of Pfizer vaccine developed vertigo requiring medical treatment and has not returned to work as of 1/29/21.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

Patient reported tingling to tongue. No SOB nor difficulty breathing. Also reported feeling light headed. No antidote nor supportive treatment given. Symptoms resolved within 30 minutes.

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines

Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.

Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired

Transient global amnesia and fall the day after vaccination Elevated ESR 51 and CRP 3 Symptoms resolved spontaneously except for labs, still monitoring

Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.

I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.

Facial flushing and light headed immediately after vaccine. Provided Juice and granola bar at 17:50. Improved after a few minutes.

AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.

Patient states feeling of light headedness. Vital signs were checked at 12:20pm. Blood pressure was 115/69, Heart rate of68, respiration 20 and sat 98%. Patient wanted to leave and was informed to go to ER if dizziness/lightheadness continues. Husband stated he understood as well.

6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.

Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.

Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.

Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction. RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.

Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.

patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.

I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.

Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.

Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Pfizer COVID-19 Vaccine EUA Patient became dizzy after receiving COVID-19 vaccination. RN took blood pressure and it was with in normal limits. Staff took employee to for examination. Employee was examined and released by provider. She stated that she was in a hurry to get to clinic and wanted to make sure that she did not miss her appointment. She is a diabetic and she has not eaten since noon and usually eats supper somewhere between 6 and 8:00 p.m (received vaccine at 5:50 PM). Pt also states she takes her evening dose of her blood pressure medication 6 PM and had not taken it prior to her vaccination. Pt also started oxybutynin 2 days ago. 1/29/21: Pt received Dose 2 of the vaccine with no issue.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests Dextrose

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.

Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have these symptoms

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.

First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.

Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.

Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.

I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I got very flushed/hot. And then light headed. It lasted about 5 minutes and I ended up staying an extra 30 more minutes. Then I was fine. No other problems.

With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.

Pt. c/o "feeling high" like she had some drink. She felt light headed. Denies SOB denies chest pain. @ 1040 BP 160/100, HR 84, RR 18. @ 11:49 BP 160/82. @ 1050 BP 160/90, HR 80, RR 18, no dizziness, Ox.Sat 97%, 160/82. Stated she is fine and wants to go home.

Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/16/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:42am Patient c/o "dizziness and mumbling noise." Patient alert, oriented, and verbal. Patient assessed in treatment area. Patient was treated/managed as follows: 11:44am VS BP 118/64, HR 67, RR 18, O2 sat 98% on room air. Patient denies shortness of breath or difficulty breathing. No swelling noted to face, mouth, or tongue. 11:59am VS BP 134/80, HR 70, RR 18, 97% on room air. Patient reports feeling better and symptoms have subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:08pm Escorted to car by sister and RN.

Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident

3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

3-9-21 12:20PM 'DIZZY - ONLY ATE A BANANA TODAY'. A/O, W/D, RESP WITH EASE, NO PAIN, NO DECREASED LOC. FAMILY AT SIDE. 12:51 'FEELS BETTER' AMBULATORYTO EXIT WITH FAMILY, GAIT STEADY. NO ACUTE DISTRESS NOTED. 3-17-21 8:49AM 'STILL FEELS LAITTLE DIZZY'. ADVISED TO CALL PCP FOR FOLLOW UP.

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function

Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes before call she became extremely dizzy. She has no history of dizziness and no history of health problems. Reports she does take Fosamax on Saturday and normally feels some nausea with that. She did take the Fosamax on 3/13/21. She questioned if this was a normal reaction and said it was severe enough that she did not feel she could walk to the office on the college campus. I recommended she call her doctor and if she continued to feel severe dizziness go to Emergency Room. I called her back at 4:54 pm on 3/16/21 and she reported she did go to the Emergency Room and they did a CT Scan and also some other tests but she could not remember everything. She said her blood pressure was elevated while in the Emergency Room. Was discharged and has a follow up appointment with her normal provider. Client called on 3/18/21 at 4:46 pm and said the dizziness continued and she was started on a steroid and meclizine by her provider.

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,

Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.

1130: Patient c/o dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased. PMHx: Epstien Barr, Bradycardia, Tachycardia Stage II Renal Disease Patient A & O x4, skin pink, warm and dry, PERRLA ~3mm Speech clear and appropriate. EMS and Physician on duty at bedside assessing patient. VS:1127:156/106-b/p, 60-hr, SaO2 96% on RA, 1141 VS: 154/104, Repeat 146/98 58-HR, SaO2 98% on RA EKG, VS as above. Patient advised to be evaluated in ED. Patient refused ambulance transport. Symptoms subsided, minimal at the time of departure ~1210. Patient taken to care via wheelchair. Daughter to transport to ED by Patient's own vehicle.

12hrs after my 2nd Covid Vaccine I was sleeping got up out of my bed at 4am and the room was spinning. I layed back down and had a burning sensation in my chest and my hands and feet were clammy. Several hours later at 8am same exact reaction when getting out of bed. Over the course of 3 days I remained Lightheaded.

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.

About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.

Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home

Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)

PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 SAT 0F100%. MONITOR STRIP DONE WITHA HR OF 112 AND REGULAR. PATIENT MONITORED ANOTHER 15 MINS WITH HR OF 90 AND REGULAR. PATIENT ISTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS RETURN.

weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon

Pt felt dizzy after vaccine. Denies any chest pain, SOB, nausea or vomiting. At this time patient feels better and does not want to go to hospital blood pressure 160/93, 98,16 150/88,84,18

Rapid Response team called for C/o dizziness, lightheadedness, weakness and numbness in all 4 extremities. She was admitted to ED

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

2nd day: Soreness of injection site 3rd day: Soreness of injection site with swelling at site 4th day: Soreness with sensitivity to touch throughout the upper part of the arm 5th day: Severe pain throughout the arm. Numbness in my fingers. light headiness, passed out for a few second. light tremors.

A short time after having received the vaccine, patient complained of lightheadedness, palpitations and was noted to have sustained high BP readings. Transported to ER via personal vehicle, refused transport. On follow up, patient reports having been started on new med for BP but otherwise recovered.

Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.

Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.

(03/04/2021) date of first COVID Vaccine, 17 days after the first COVID Vaccine I am experiencing vertigo, fatigue, abdominal discomfort, (all day) if I am active and have food in my stomach I will vomit. Received the second COVID Vaccine (03/05/2021) after returning home from the vaccine I vomited multiple times that day. Symptoms have not improved. Went to the doctor on 03/29/2021 for an evaluation. She recommended a COVID test. The test was negative. The Dr said my condition is an adverse reaction to the COVID Vaccine

3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night. 3/26/2021 same as previous day. 3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed. Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose. Lasted close to one hour. 3/27/21 most of afternoon & evening extreme tiredness. 3/28/21 morning ok, by afternoon extreme achy tiredness again. 3/29 to present headaches.

I had my Pfizer vaccine on March 16, 2021. On March 17th I had a headache, body aches and fatigue which I expected since I had Covid in November 2020. Most of these symptoms only lasted 3 days. After the 3 days I had a continuing headache and started having jaw pain. On March 22nd I started having dizziness and a severe headache with jaw pain, fatigue and nausea. On March 23rd I got up abruptly and felt extremely dizzy and almost passed out. I am having continued sporadic headaches, nausea, dizziness behind my eyes with fatigue and a metal taste in my mouth especially when my mouth is dry. As of March 30th, only side effects lingering are dizziness behind my eyes and nausea

Participant c/o dizziness and feeling "tingly all over". States has had numerous allergic reactions in the past. B/P 180/98, pulse 81, O2 sat 96% EMS arrived and assessed participant; B/P 188/ 118. Continued to complain of ongoing symptoms, agreed to go to E.D. to be further assessed.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 times, had a harder time breathing, than normal being on oxygen. Stayed in bed for approximately 27 hours, just couldnt function well. Didnt contact Dr. About it, had family stay with me for couple days. I know it was from the vaccine.

Participant c/o of HA, dizziness and left side jaw numbness prior to exiting covid monitoring area; est. about 20 minutes post Pfizer Covid vaccine 1st injection. 1313 Escorted to covid monitoring cot and placed in semi - reclined position. 1317 BP 148 /88, P 79, R 18, 62; denies medical hx and allergy to any meds / foods. 1319 O2 sat 98% and participant voiced decrease in HA with no jaw numbness or feeling of heart pounding; denies numbness to upper extrems. 1324 BP 151/92, P 82, R 18, O2 sat 97% with participant voicing "it's all related to anxiety due to lots too for the day". 1332 Call 911 to site for response. Participant aware of call at time. 1337 Bp 176/102, P 82 and sitting on sit of cot. 1332 EMS on scene and assessment begun. 1345 Participant declined EMS support / transport to hospital. 1348 Ambulated to restroom with assist with no c/o; voiced "feels much better at time". 1350 Provided education on s/s to call 911 for immediate f/u and encouraged to notify PCP of event post vaccination. Participant voiced understanding and shared is scheduled to see PCP on 03/24. Discharged from site into self care with ambulation to car.

received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.

Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger. Difficult to hold my phone while waiting, I dropped it, then started to get dizzy. Called a volunteer over, who summoned another lady. They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out. When they were lying me down on the floor, I came to and was oriented at that point. BP was somewhat low initially, but increased as I lay there, and oxygen levels increased from 94 to 99 before I left facility.

Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.

Patient had received covid vaccination and had ambulated over to monitoring area. Complained of dizziness and severe headache. States no history of migraines/headaches or dizziness. Assisted patient to sit down. b/p 161/111 hr 90 sat 98%. 1650 EMS called. 1651 140/76 HR 68 Sat 98% Neuro intact. alert and oriented. States does not take any home medications, no HX HTN. NKDA. 1657 EMS on site. Patient adamant that will not go to hospital. ems waiver form signed. 1657 BP 151/79 HR 70, Sat 98%. Patient denies further dizziness or headache. 15 minute monitoring time was to end at 1651. Patient stated felt better and wanted to go home and left facility.

Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.

11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness, lightheadedness, inability to get out of bed, dry heaves 23 hours after?attempted to get out of bed, fell/collapsed/fainted sustained many bruises

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Pfizer Covid 19 EUA The 61 YOF felt dizzy in Observation and was seeing spots. Upon further talking to her and her husband she has a history of anxiety. All vitals were within normal limits. She rufused treastment and transport. ED was contacted and an AMA was completed. Her husband was with her and assured us if she had any more issues he would take her to the ER. 2021-000202257

Relapse of Multiple Sclerosis symptom; Extreme vertigo; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6204, Expiration Date: unknown), via an unspecified route of administration on right arm on 15Mar2021 10:00 AM at single dose for Covid-19 immunization.The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9267, Expiration Date: unknown), via an unspecified route of administration, on right arm on 22Feb2021 9:00 AM at single dose for Covid-19 immunization. Patient medical history included Multiple Sclerosis. No Allergies to medications, food, or other products was reported. Concomitant medications included other medications were received in two weeks. On 16Mar2021 at 03:00 AM patient experienced Extreme vertigo and aches in her bones concentrated in her hips and lower back. It also triggered a relapse of Multiple Sclerosis symptom as and she had significant difficulty walking. The pain has continued for days. She had been taking high doses of Aleve for days for the pain. Facility type vaccine: Pharmacy or Drug Store. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior and post to vaccination, the patient was not diagnosed with COVID-19. The outcome of event was not recovered. .

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

-SLUGGISH, HEAVY, SHORT OF BREATH -WEAK, UNSTEADY -INSIDES FELT 'BURNING' -WENT TO URGENT CARE NEXT DAY FOR TEST; NEGATIVE -BREATHING TX; STEROIDS; INHALERS PT STATES SHE IS BETTER NOW.

pt. c/o dizziness, alert, and verbally responsive. no change LOC mild lightheadedness. :12:20 vitals- 77bpm, 19 cpm, 97%o2 106/60 BP 12:40 vitals - 79bpm, 18, cpm, 98%o2, 109/71 BP #21 pt. went home

1425 Pt reported feeling light headed and dizzy. VS: 125/61, 75, 95% RA, Temp 99.0. Pt was given water to drink and observed for additional 10 minutes. 1445- Pt reported feeling "much Better" and left site at 1451 - RN

On 3/30 PM, I experienced very severe nerve pain in lower extremities and muscle weakness that last over 48 hours. I was initially very unstable walking for first 24 hours. Symptoms were very similar to severe reaction in 2018 with yellow fever vaccine (Sanofi) but not as severe. Home treatment with Aleve 200 MG every 3 hours. Recovery on 4/4

5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNESS IN HER LEGS. SHE LOOKED PALE AND HER SKIN WAS CLAMY. GAVE HER SOME WATER AND 1 GLUCOSE TABLET (4GRAM CARBOHYDRATE). TOOK HER BLOOD PRESSURE AS WAS LOW AT 76/51, RECHECK 86/62, RECHECK, 86/58. ATTEMPTED TO CALL 911 BUT PATIENT REFUSED AND WANTED HER DAUGHTER TO COME GET HER. AT 3:54 PM SHE REPORTED THAT THE DIZZINESS WAS GETTING BETTER AND BLOOD PRESSUER RECHECK WAS 98/68. AT 4:01 HER BLOOD PRESSURE WAS 117/71 HR 73 THEN EVENTUALLY CAME BACK UP TO 128/80 AT 4:08PM. PATIENT LEFT AT 4:17PM. WILL FOLLOW UP WITH A PHONE CALL TODAY.

High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.

patient complains that she feels dizzy. no chest pain or sob. no nausea or vomiting. no sensation of fainting.

Heavy arms feel, dizzy observation. Patient states she has high blood pressure; no meds given/patient states feeling fine

shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass nest couple days blood pressure mildly high and then extremely low, dizziness, nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable

Client c/o nausea and dizziness. Client evaluated by Fire Rescue, Symptoms resolved. Vitals WNL. Per Fire Rescue, no further evaluation needed. Client transported home by husband at 4:30pm.

Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered feeling as if a fast heart rate; Difficulty lifting arm; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 16:00 (Batch/Lot Number: EL9262) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension), Elevated Cholesterol, glaucoma, GERD (gastroesophageal reflux disease) and Known Allergies: black pepper. The patient's concomitant medications were not reported. The patient previously took Flexeril, codeine and fentanyl for all these drugs experienced drug hypersensitivity. Initially a fluttered feeling as if a fast heart rate, but 60 second counts revealed pulse regular and no more than 80. Arm soreness; pain about 10 minutes after injection. Continued despite use of Tylenol and heat packs. Difficulty lifting arm; pain impulses upon lifting of arm on 23Jan2021 16:00. The patient underwent lab tests and procedures which included heart rate was 80/min. The outcome of the events was unknown.

Debilitating Vertigo when she rolled over in her sleep. Bad pounding headache, nausea and vomiting for 24 hours, then able to take some excedrin and meclizine and stopped vomiting. Could only drink some liquids for first 2 days, this morning finally able to eat some toast and tea.

Chills, fever of 101 degrees, severe headache and body aches. Took Tylenol every six hours over the course of four days. Due to my Meniere's disease, these symptoms also exacerbated balance issues for seven days total.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

evening fever, chills, body aches all over , dizzy,sick,tried,headaches diarrrha and still having head ache and dizzy and diarrhea

I became extremely tired. I also got a bit dizzy and HAD to lay down for a few minutes. The dizziness stopped but I had to sit down about 15 minutes later and sat for about an hour to rest. I was fatigued the rest of the day. The second day after the vaccine I was also fatigued but could keep my regular schedule.

Muscle and joint pain with weakness in left arm. The left elbow joint pain was so severe I was unable to flex my elbow to touch my face for over a week. Also, have continued joint pain in my hips and back. The symptoms were expected but have continued for over 2 weeks. The side effects after my first dose ( chills, muscle aches , headaches, fatigue and pain in my left arm) resolved completely after 72 hours.

Pfizer Covid-19 VAccine, mRNA, LNP-S, PF, 30 mcg / 0.3 mL dose. Carton, 195 Multi-dose vials. REACTIONS: Day #1 April 8th. Soreness, tenderness, mild headache, feeling unwell. Day #2: Very sore, tenderness, Headache, feel unwell. (Note: Was not able to lift my Left arm fully this day.) REDNESS at muscle injection site Did Not appear until Late evening, about 8pm on Day after vaccine given. Day #3 (date of this report): Still tender, Redness, Arm more mobile, able to lift up after late evening of Day #2. I'm taking MOTRIN IB tablets - 2 tablets every 8 hours. It was really for some slight nerve pain in my Rght thigh area, But ti has helped with Soreness, and diminished redness at injection site of the vaccine. RE: FACT SHEET for Pfizer Vaccine. Lists "Risks of Vaccine, Side Effeects.) Here is my List; Day #1: Injection site pain, tiredness, headache, muscle pain, feeling unwell. Day #2: Injection site pain; tiredness, headache, muscle pain, injection site Swelling, Injection Site Redness. Day#3: Site pain; Swelling , Redness.

swelling of tongues and upper inside plate; upper inside palate in her mouth was also kind of swelling; upper lip tingling/numbness and swelling of tongues and upper inside plate; muscle soreness near the injection site; injection site was painful; couldn't move her arm behind her or up and was limited with that arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 22Mar2021 10:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was in generally good health besides being hard of hearing and she got hit by a car at age 2 and after she got older her HCP said she would be completely deaf by age 60 and she was now classified as being profoundly deaf. There were no concomitant medications. She had never gotten the flu shot in her life. The patient experienced had muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm on 22Mar2021, numbness and swelling of tongues and upper inside plate, upper inside palate in her mouth was also kind of swelling and upper lip tingling, all on 22Mar2021 19:00.There was no treatment received. She had physician office visit to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this. The clinical course was reported as follows: She had the 1st dose of the Pfizer Vaccine on 22Mar2021 at 10:15am and for the most part where the injection site was and some in the muscle it was very painful and she was told this is very common; the vaccine was given in her left arm into the muscle and the injection site was painful for a while and then the muscle below it felt painful and throughout the day and yesterday she couldn't move her arm behind her or up and was limited with that arm on 22Mar2021. Today the pain was getting better and the muscle and injection site still are kind of sore but she was sure that would get better in time. Around 7:00pm(22Mar2021 19:00) in the evening she had another reaction that was not listed in the severe reactions and that was she had some numbness and swelling in her tongue and then the upper inside palate in her mouth was also kind of swelling and her upper lip was tingling; states this swelling and tingling began on 22Mar2021 and was not ongoing fortunately she slept sitting up and did not want to lie down and suffocate herself; when she woke up at 4:30am the swelling and tingling went away so she does not know what time the symptoms went away because she was asleep. She had no treatment and tries to avoid medicine as much as possible and did not go to the emergency room but following yesterday she went to the walk in clinic last night because she wanted to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this, and the HCP said there is nothing he can do. Case were assessed as non-serious by reporter. Outcome of muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm was recovering, of other events was recovered in Mar2021. Information on lot/ batch number has been requested.

Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my 15 minute wait time before leaving, I told them my experience. They took my blood pressure which was 175 over something. They let me leave when it was down to 144 over something. Within a few minutes after we left I experienced a severe hot flash, my air cutoff, and I felt weak/faint. I experiencedy airways close, then open again. Nothing like I have experienced before with an asthma attack. This was different. My husband pulled over and I was able to call 911. My heart was racing. The paramedics asked me about the rash on my chest which I new nothing about until he mentioned it. Said my face was flushed? And

Upon receiving 1st dose, pt ambulated to observation area w/ unsteady gait. Pt sat down in observation area w/ noticeable labored breathing, inspiratory stridor, cough, dyspnea. Pt was pale and diaphoretic. Pt was offered vitals check by medical staff, pt refused, stating she recently had an AMI and this was normal for her. Pt stated she carried EpiPen due to latex and iodine allergies, and "if this was an allergic reaction," she "would have known by now." Pt was told to notify medical staff of symptom changes. Throughout her 15 minute wait, pt produced violent coughing and could be seen with noticeable SOB. Pt stood up and ambulated with unsteady gait for approximately 5 ft, where she stopped and was assisted into w/c. Pt was wheeled out to vehicle, where she was asked to stay for another 15 minutes given her symptoms, pt refused. Pt was offered vitals check, pt refused, stating she is "just a minute away from home" and if she would place herself "on low oxygen" upon arrival. Pt drove off, returning approximately two minutes later. Pt c/o throat swelling, SOB, w/ inspiratory stridor, hoarse voice, and violent cough. EMS was called at this time. EMS transported to local hospital.

LIGHTHEADED/ ACUTE HEADACHE INITIAL BP 143/98mmHg - [30 MINUTES POST] BP 139/88mmHg Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.

Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home. She said for a while she felt like she couldn't swallow. She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.

Lightheadedness, almost passed out so they kept me longer & it happened again. Had to pull over side of road on way home as I almost blacked out. Happened throughout the day and then my blood pressure went to 160/90. That has lowered but still has not returned to normal.

Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weakness, and Shuffling Gait. Denies Respiratory involvement. Vital Signs Stable No Rash observed. Patient reports s/s started while shopping at shopping center three hours after injection. Reports history of Anxiety and reports taking Xanax the night before the Covid Appointment.

Patient received vaccine this morning and while in observation room at 0924 brought attention to RN that feeling lightheaded and tired. Patient brought to side room, sat on stretcher and placed on monitor. VSS at 0924 O2 sat 97%, HR 64 and BP 146/73. Patient stating she is feeling better and did take BP meds this morning. Patient had difficult drive in and stated some anxiety from that situation. She did lay down and was given water after c/o of stomach upset.. 0930 VSS O2 97%,HR 60, BP 131/79. VSS at 0940 O2 sat 99%, HR 56, BP 138/89. Patient stating feeling much better , last set VSS O2 sat 97%,HR 56 and BP 131/79. She sat up and stood without issue. Felt comfortable to go home.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

had an immediate reaction of dizziness, lightheadedness and throat closing within 10 minutes of getting the Pfizer vaccination. Was given two zyrtec and that improved. She did have the symptoms for about an hour after and then was completely back to normal. States she has had a reaction to Miralax in the past and has not taken it since that reaction. States she is also allergic to Sulfa medications. Will refer to allergy

Patient reported numbness and tingling in both arms, nausea and dizziness starting 4 hours after vaccination. Patient reported that she went to the ER and adverse events resolved on their own after about 4-5 hours (by 6pm).

reported feeling "lightheaded" 20 mins post vaccination. h/o "anxiety with needles & injections previously by report. Denies any other symptoms - no resp difficulty . lungs clear. TX- mask removal; fresh air flow; emotional support 7 car seat reclined. additional wait time - left lot with spouse driving vehicle.

At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.

Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn't stand for more than a few minutes without support. The third day still a bit lightheaded/foggy, but much better than the day before.

Patient received first Pfizer Covid-19 immunization on 4/12/2021. The shot was administered at 11:01 am into the left upper deltoid. Approximately 3 minutes later patient complained of faintness and experienced syncope. Patient was able to lie on the ground without assistance and her legs were elevated. Emergency services were placed on standby, and a first responder from the fire department was on hand. Patient was responsive and alert, citing tingling in her left arm and an irritated, scratchy throat. Diaphoresis, but no signs of dyspnea or acute anaphylaxis. Blood pressure elevated. Supine position with elevated legs maintained for about 30 minutes. Patient declined EMT evaluation and was able to leave without assistance.

after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down assisted to stretcher placed in trendelenburg snacks and water and juice provided bp elevated sat up bp cont to be elevated pt states having anxious thoughts about covid vaccine expressed to nurse bp elevated pt agrees to lay down and rest for a few minutes and close eyes deep breathing exercises enc to pt. per pt stress relieved after a few minutes and feeling better and requesting to leave, escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home. pt left at 1053 vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95, 1020 bp 157/91 hr 80 rr 18 o2 98 1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84 1051 148/89

1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizziness. 11 days later extreme anxiety. 12 days later chills, body ache, fatigue, and anxiety. 13 days later severe ocular migraine.

left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel worse it is 9:50am . can barely move left leg

dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

4/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1229 Alert and oriented. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS are BP- 155/94, P- 55, O2- 100%. Water given, patient refused food, she reports that she has not eaten today and refuses any food. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/20/2021 12:11 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc

strong headache focused behind eyes, moderate body aches and chills and fatigue, minor dizziness and nausea, slight cough. All beginning at around 6 pm (9 hours after shot) and ending around 5 pm the next day. Fatigue continues.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

Dizziness and lightheartedness that was not treated with medications. 20 min later patient reported mild dizziness. Patient drank 2 bottles of water.

At 11:27 AM, Pt states that within approximately 10 minutes of receiving Pfizer vaccine pt c/o tingling ?to roof of her mouth?. She notified RN of symptoms and nurse asked her to open her mouth and observed that tongue was WNL without swelling, speech clear, no respiratory distress. Discussed with Pharmacist and instructed pt to wait another 15 min and to sit close to nurse for observation. RN also asked pt to notify her of any worsening of symptoms and also to not leave site without evaluation of nurse. At 11:42 AM pt stated symptoms were worsening and c/o think tongue, numbness, tingling of lips. Denies any SOB or difficulty breathing. Lungs clear to auscultation posteriorly all lobes.B/P 180/110, Left arm, Pulse ? 100. Pt also c/o blurred vision, numbness across forehead, chest pain and pressure, dizziness and increased tiredness, denies headache and anxiousness. At 11:46 AM 12.5mg liquid Benadryl given p.o. and after consulting with Pharmacist, another 12.5mg Benadryl given at 11:51AM and pt taken to ED via wheelchair. Pt verbalized consent.

Pt received her vaccine and completed the 15 minute observation period with no adverse event. She felt dizziness upon standing. She drank a bottle of water, but remained dizzy. Pt was escorted to the restroom by medical reaction nurse, at which time she reported ongoing dizziness. She was brought to medical observation unit at 2:33pm. Associated symptoms included shortness of breath. SPO2 was 86 upon arrival to medical observation unit. 2:39pm- pt reports resolution of SOB; 2:44pm- pt reports resolution of dizziness while lying supine; 2:52pm- pt reports slight lightheadedness while sitting upright; 3:00pm- pt denies dizziness/lightheadedness while sitting upright; 3:02pm- pt denies dizziness/lightheadedness while standing PT discharged home at 3:04 by herself Vitals as follows: 2:34pm- HR- 74, RR- 18, BP- 174/75, SPO2- 96 2:39pm- HR- 66, RR- 16, BP- 166/90, SPO2- 97 2:44pm- HR- 69, RR- 18, BP- 147/93, SPO2- 96 2:52pm- HR- 69, RR- 18, BP- 164/80, SPO2- 95 2:55pm- sitting- HR- 70, RR- 16, BP- 156/96, SPO2- 96 3:00pm- sitting- HR- 70, RR- 16, BP- 151/85, SPO2- 97 3:02- standing, HR- 79, RR- 16, BP- 144/86, SPO2- 96

Was walking my dog the next morning, started out fine, halfway through I was dizzy and nauseous and had to sit down. I put my head between my knees and was sweating though it was 30 degrees out. I threw up 3 times (empty stomach so mostly spit and stomach acid). Took about 10 minutes to feel a bit better to make my way home. Tired and nauseous the rest of the day. Had a wonky stomach up until Sunday (shot was on a Wednesday).

I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a nerve in my back but had no sensation of this until acute pain from mid upper back across shoulder and down right arm. Began exactly 12 hours post vaccine. And woke me from deep sleep. Could not get relief for several days until I contacted provider and was given Flexeril and Aleve. Could not lay down or sleep due to position of nerve in my back. (Vaccine administered in Left arm. ) Have never had a problem previously like this in my back. I exercise regularly. I surmise that if this nerve was aggravated, the inflammation induced by the vaccine made this worse where no vaccine and I would not have had a problem. Friday followed with typical side effects of lethargy and tiredness. Experiencing slight mobility issues in right arm post 13 days vaccination.

On the 15th day after vaccination with Pfizer vaccine, I got dizzy for a few seconds while laying on my couch. Within a few hour after that I started with loud ringing in my right ear; this happens to be the same side I was vaccinated on. That same night I got a headache and was throwing up. The louder ringing in my ear lasted few about two and a half weeks. Since then is has gradually been subsiding.

On 4/18 had fever and aches, but was better and able to work on 4/19. Rash broke out on 4/20 on R anterior shin (somewhat linear set or erythematous papules - look like broken vessels from when an area is scratched, but she denies scratching; lesions don't blanch), back of neck (wide area of erythematous maculopapules with a hint of some mild swelling/raised appearance), over L hip. Patient reports that it doesn't itch or hurt. She did think they were swollen at a point. Patient is also feeling a bit dizzy, with some nausea and a little diarrhea.

I woke with a migraine headache on the 2nd day after my vaccine and the migraine lasted 28 days in a row, 24 hrs each day. I lost my appetite which led to a 30 lb weight loss, I was dizzy, and fatigued. Furthermore, I was given tramadol, but it did not help and contributed to the dizziness so discontinued that after 1 week.

Sore arm starting evening of injection, continued through second day (at time of report) Extreme dizziness starting morning after injection.

headache and pressure; dizziness; nausea followed by vomiting; intestinal discomfort; extreme tiredness followed by sleeping for about 11 hours straight. These symptoms were almost completely gone by the following Monday (3/15/21) when I received the second vaccine.

felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.

Patient complained of dizziness and headache after second Pfizer dose. Patient was monitored and discharged to home.

Severe joint pain whole body 4/23,4/24 Headache-still have Heart palpitations 4/23 Muscle pain 4/23,4/24 Dizziness -still have

Slight constant headache since the first dose of the Pfizer vaccine. I did not have headaches before, or in years! Sometime dizziness.

Approximately ten minutes after receiving vaccine. Patient began experiencing an itchy throat, dizziness and throat tightness. Offered Benadryl, which patient refused. Was monitored for 30 minutes with resolution of all symptoms.

Slight numbness in tongue that lasted several hours beginning within 10 minutes of vaccine along with dizziness; experienced fatigue, nausea, tinnitus, blurry vision in right eye, elevated heart rate, buzzing sensation in back of head, stabbing pains in stomach followed by profuse watery diarrhea. Dizziness and nausea still unabated seven days following vaccination.

Patient received COVID19 Pfizer BioNTech vaccination approximately 2:20p. After vaccination administering provider requested patient wait for 15 minutes prior to leaving. Approximately 2:22p patient began to feel faint - lightheadness, clammy skin, sweating and pale skin. Patient fainted at 2:24p. Patient remained in her chair and did not slump nor fall out of the chair. Two pharmacists were with the patient to assist the patient to the floor if needed, however was not necessary. The patient regained responsiveness within a couple of minutes. When regaining consciousness the patient was alert and oriented. She was provided a water and cold coke. Upon questioning the patient revealed the only thing she had eaten for the day was a muffin at noon. The patient stated feeling weak and hot. The patient was offered a snack, however declined. After drinking some of the coke the patient began to feel better. Patient was not diabetic. At 2:37p the patient's blood pressure was 114/81 and had a pulse of 95. The patient remained in her chair with supervision while coordinating a ride from her husband. Per the patient request she was transported to the front of the store at 2:50p via wheelchair to wait for her ride. She was picked up by her husband at 3:00p and was able to get out of the wheel chair and into the vehicle under her own power. The patient was instructed to continue to rest, hydrate, and eat something upon arriving home The husband was informed of the situation and informed if her condition worsened to call emergency services for additional help.

Patient came in feeling anxious about the vaccine. RPh spoke with her for 5 minutes before giving the vaccine and she felt calm and reassured getting it. 10 minutes after vaccine patient complained of feeling lightheaded and that her heart was racing. She said she took no blood pressure medicine and that it was controlled with a "Zeal" drink. RPh checked her blood pressure 3 times, with the last reading being 174/100. RPh advised patient to go to the ER. With her consent we called 911 and EMS arrived. They checked blood pressure again and it was 194/105. She said she felt calmer and didn't want to go to the ER. I told her to call her PCP as soon as she got home. I followed up with her after she got home and she said she left a message with the Dr. I had her check her blood pressure and she called back a few hours later and it was 134/88. RPh advised her to continue monitoring it a few times today and make sure she speaks with the doctor before the weekend.

First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, chills. Had trouble sleeping the following night of the vaccine with nightmares, unable to sleep at all, just plain felt miserable and had difficult time getting out of bed.

Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she started to get up to leave as she had sat there for 30 minutes. She does admit to having some anxiety about getting the shot as she has had an anaphylaxis reaction to both pyridium and macrobid requiring ED intervention. She carries an epipen with her. She is on Metoprolol as she throws quite a few PVCs. BP at 11:55 am 186/88- pulse-64 and ox reading 97%. Encouraged to drink some water to hydrate as has not drank much today. BP at 12:05 pm BP=184/84 and light headedness has resolved and able to leave. Card with contact information given to Client if any other side effect should be experienced. Encouraged her

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.

reported to ER with 1 day history of change in status of left arm weakness/imbalance with walking. Within 1 day symptoms were improving by time of presentation to ER. Ultimately was admitted and found to have an area of 1 to 2cm area of acute infarction in right posterior frontal lobe found on MRI after initial CT scan and other labs were normal.

Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.

Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours

She got her vaccine, no reaction to the arm, no arm pain, nothing. Then that evening 3 hours later she could hardly walk when she stood up. Her right side of her body starting from hip to inner thigh and stabbing pain in her groin area with any step she took. Firing pain to her hip and inner thigh. She was limping that evening and went to bed, and when she woke up with stabbing pain in her hip and groin area and unable to walk at all. She had to scoop around in her office chair as she is OK to sit, but when she takes her first step on the right side has the stabbing pain until her body (warms) up for at least the first several steps at least. She did go to her doctor and he prescribed Diclofenac sodium 75 mg twice daily for the inflammation and should go away within a week or two, but it has been almost a month and the symptoms have not gone away. Her hip area has gotten much better, however, her groin area has gotten worse. It's at the point that she can walk, but she grimaces and hurts once she's able to get up and walk. In the right groin she can distinctly feel the sharp stabbing pain as she walks. Again, as long as she's sitting she is okay, but upon trying to walk the first 5-6 steps it is painful. The longer she walks the pain diminishes more. She did not have these symptoms prior to the vaccine. She did not fall or do anything to injure herself. She is now going to restart taking the medication he prescribed to her. First vaccine had foot pain on the right side that went away by the next day.

Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

BNP just went up and up; Congestive heart failure; She couldn't walk up the stairs; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021 (Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation, in the afternoon around 4 or 5 o'clock. Vaccination Facility Type was Nursing home/Rehabilitation Center. Medical history included psoriasis from 1986 and ongoing; stent in 2016, the doctor was sure the heart failure was not related to her stent; swollen leg from Jun2020 to an unknown date. She went to her Cardiologist, they said she has no heart failure. The Cardiologist told her the fluid from her knee drained down into her ankle that was why it was swollen, her BNP indicator was 165 at the doctor then. Concomitant medications included atorvastatin (LIPITOR) taken for cholesterol, coronary artery disease, cardiac disorder from 2016 and ongoing; clopidogrel bisulfate (PLAVIX) taken for blood viscosity decreased from 2016 to 14Apr2021, patient reported when she went to the hospital they checked for a PE or Pulmonary Embolism or blood clot, they found nothing, the cardiologist said her blood was flowing beautifully so he discontinued the Plavix; acetylsalicylic acid (BABY ASPIRIN) taken for blood thinner from 2016 and ongoing; ezetimibe (ZETIA) taken for blood thinner, start and stop date were not reported. The patient previously took the first dose of bnt162b2 on 11Jan2021 (lot number: EL0142), also at age of 61 years old, at left deltoid for covid-19 immunization; tremfya injection 100 mg every 60 days for psoriasis. The patient experienced congestive heart failure (CHF) (hospitalization, disability, medically significant) in Feb2021 with outcome of not recovered, she couldn't walk up the stairs (hospitalization) in 2021 with outcome of unknown, bnp just went up and up (hospitalization) in Apr2021 with outcome of unknown. The patient was hospitalized for events from Apr2021 to 16Apr2021. Patient report she got short of breath, which she didn't attribute heart failure, she thought it was something with her lungs. And had a cough. She reported she was so short of breath she couldn't walk up the stairs. At the beginning of the month, she was better, but she couldn't go up the stairs, and she was taking cough syrup and things which didn't help. Then she was in the emergency room either on 13Apr2021 or 14Apr2021 and then she was admitted to the hospital, and then she had CHF. This started 2-3 weeks after getting the 2nd vaccine the shortness of breath, heart congestion and wheezing. Her husband said she needs to go pulmonologist to be seen. Patient confirmed she went into the hospital on the 13Apr2021 but, it was midnight and it could have been the next day also, it varies, the time. The shortness of breath and things started in February or March started, they started slowly. She could not breath at all, it started around 2-3 weeks after the vaccine. It was so bad she could not walk around, her husband was worried he went to get the car and she waited on a bench. She could not breath. These things started before 16Mar2021, maybe, between the 15Feb2021 to 21Feb2021. Patient said CHF was heart didn't pump sufficiently anymore. She was now on disability and has a Life-Vest. She was on tons of medications. She wears Life Vest for 3 months then will get echocardiogram or MRI to see what is going on. When she went to the hospital for the CHF, her BNP was 2700 and then it went to 3500. They gave her IV diuretics in the hospital but her BNP just went up and up. This was all on the same day she went to the ER, she spent 13 hours in the emergency room. They drew labs and cardiologics then. Patient got IV diuretics in the hospital, she believed it was Lasix or Furosemide. When she was discharged for the hospital at night on the 16th, her BNP was 518, so they let her go because the diuretics worked. The diuretic was change to oral Torsemide at her discharge. Investigations included chemistry, BNP, a blood count, a metabolic panel.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Cardiac failure congestive, gait disturbance, brain natriuretic peptide increased cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.

Pt felt light headed, VS taken, Pt refused EMS, Orange juice provided, pt states she feels better, Pt released via wheelchair & nurse, spouse at side

Heart palpitation's -- increase heart rate followed by low heart rate and dizziness off and on for one week .

Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.

Patient complained of being dizzy, couldn't breath, unable to move L arm. L side of back numb also complained of legs hurting but stated legs had hurt all week. BP 138/70 HR 81 O 2 sat 97% glucose per fingerstick 212 equal grip, PEARL, Respirators 22 Transported to local hospital via ambulance for health care

Diarrhea; Stomach pain; Stiff neck; Vertigo; Swelling of hands and feet; skin dryness and cuts appeared; skin dryness and cuts appeared; She did not have any smell and taste; She did not have any smell and taste; Fever; Chills; Coughing; Her lymph node glands were swollen between her legs; Right arm was of no use it was so painful it felt like it would break off of the shoulder; Nauseous; Dizzy; Difficulty walking; Exhaustion; The moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut; Tachycardia/heart beating out of her chest; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:30 (Batch/Lot Number: EN6198) age at vaccination of 61-years-old at 0.3 ml single for covid-19 immunisation. Medical history included bell's palsy from an unknown date and unknown if ongoing, endometrial cancer from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), rubber sensitivity from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing (sick for the past 11 years). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included levofloxacin (LEVOFLOXACIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and experienced hypersensitivity, mycin [benzathine benzylpenicillin] and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Hospital. On 25Feb2021 at 1230, she was dizzy, nauseous, vertigo, swelling of hands and feet, tachycardia/heart beating out of her chest, difficulty walking, her right arm was of no use it was so painful it felt like it would break off of the shoulder and her left arm was the arm she got the shot in and it had no reaction at all, she did not have any smell and taste, fever, chills, coughing, her lymph node glands were swollen between her legs and the other weird thing is that the moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut, skin dryness and cuts appeared, she could hear the noise of it opening up on fingers it was like a popping, she had a stiff neck and like everyone she had exhaustion. The patient experienced stomach pain and diarrhea on 27Feb2021 those are the things she had and her family won't leave her alone, they think she should get the second injection but she is terrified. She has gotten no help from her doctor. No treatments were given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28Nov2020 (Nasal Swab). The patent was not recovered from the events. No follow-up attempts are needed. No further information is expected.

Vertigo; Nausea; Dizziness; This is a spontaneous report from contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0176 or EW0178, Expiration date: 31Aug2021) on 11May2021, at 16:00, at single dose, in the left upper arm, for COVID-19 immunisation. Relevant medical history included allergies to codeine. The patient previously, on an unspecified date, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0164, Expiration date: 31Aug2021) 0.3 ml, single dose, in left upper arm, for COVID-19 immunisation. Concomitant medications included topical steroid-name unknown, stopped 2 days before this report. Medic said to not be concerned because it was a topical cream. On 11May2021, the patient experienced dizziness after getting the vaccine. Sat there a few minutes and felt better, got up and walked to the sitting area. She sat for 30 minutes, got up and drove home. She had seen the medic prior to getting the shot because she has allergies to codeine. On 12May2021, around 02:00 am, the patient developed severe dizziness, vertigo and nausea. Treatment was none. The patient did not recover from vertigo, while clinical outcome of the other events was unknown. Seriousness criteria was not reported for the events. No follow-up attempts are needed. No further information is expected.

Severe headache; extreme body aches; extreme fatigue; light headed when not lying down; feeling like I was going to vomit if not lying down; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in arm left on 26Feb2021 09:45 as single dose for covid-19 immunisation. Medical history included high cholesterol, penicillin allergy, allergies to sulfa and covid-19. Patient previously took thiomersal and had allergy from it. Concomitant medication included rosuvastatin (other medications in two weeks). The patient did not receive any other vaccines within 4 weeks. Patient had covid prior vaccination. The patient was not tested for COVID post vaccination. On 26Feb2021, the patient experienced severe headache, extreme body aches, extreme fatigue, light headed when not lying down, feeling like I was going to vomit if not lying down. The treatment was not received for adverse event. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Chest pain a few weeks after injection 1/28/21. Next day after injection headache, dizziness, nausea

4/24/21 At about 6pm I started to feel pain on right side from groin area down to my legs by the next morning I was not able to walk. The pain would radiate and it was a stabbing pain around the groin area. I started to walk and it would numb out. The next morning I called the emergency line and the doctor assure me it would be a reaction and it shouldn't take more than a few days. after a week he prescribed medicine for inflammation they didn't work another week later I was prescribed Gabapentin 300mg 1x a day

Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a few hours of receiving the vaccine. By 4:30am on 3/31 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. This is about 1.5 weeks post vaccination. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. Symptoms began within hours of vaccination. She was take to the hospital the morning after the vaccine and never came home. Patient died after 2 weeks in the ICU.

At 1:30 patient with heart palpitations. Patient verbalized " I feel my heart skipping". Denies chest pain, shortness of breath. Slight dizziness noted. No change in LOC. Denied nausea and vomiting. Patient assisted to gurney in sitting position. Patient was given water and snacks as requested. 1:33pm - vital signs monitored - v/s signs BP - 165/80, pulse - 81, RR - 18 & 02 sat - 99% RA 1:45pm - Patient felt numbness on Left arm, patient refused to have vital signs taken again x3. 911 was called per patients request 1:52pm - paramedics came to evaluate patient & sent to hospital for further evaluation

bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F

ALS; Profound fatigue; weakness; joint pain; Difficulty getting up from a crouch position; This is a spontaneous report from a contactable nurse reported for herself. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:15 AM(Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 61 years old. Medical history included Damage from spinal cord tumor at C2, s/p resection, s/p ablations for cardiac arrhythmia, amyotrophic lateral sclerosis, Allergies. The patient's concomitant medications were not reported. The patient experienced ALS, profound fatigue, weakness, joint pain and difficulty getting up from a crouch position, all on 03Apr2021 with outcome of recovering. Reported Event: Profound fatigue, weakness and joint pain. Difficulty getting up from a crouch position to the point that she googled 'how to get up off the floor'. She was worried she had Amyotrophic lateral sclerosis (ALS.) This progressed to having difficulty getting both up and down, even from a chair. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event ALS was serious as medically significant. No treatment received for events. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event ALS is unrelated to bnt162b2 vaccination, but more likely due to underlying or inter-current medical conditions. The patient has medical history of amyotrophic lateral sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Adverse event: PT received second dose of Pfizer on cot laying supine r/t anticipated vaso-vagal reaction. PT sat on edge of cot 5 minutes post vaccination. Daughter translated for PT, who reported she was "feeling fine". Daughter assisted PT to stand and then back to a seated position, then to lay on cot. PT became unresponsive, breathing was normal, pulses were present. EMTs were called at 1525, arriving at 1526 and assessed PT. PT had improved enough at 1540 to c/o feeling "dizzy, room spinning". Daughter reported that PT "does this a few times a month." and reported that PT had recently been evaluated by neurologists and cardiologists with no abnormality found. EMTs assisted PT to sit up on cot, but PT was unable to tolerate sitting for more than 1 minute and was assisted to lay supine again. EMTs called for transport to Hospital. PT remained lethargic, with eyes open, and responding to daughter. Treatment: EMTs were called at 1525 and arrived at 1526, assessed PT. VS at 1525: 158/78 BP, HR 86, RR 16, SPO2 100%, BS 316. VS at 1533: BP 156/76, HR 77, RR 20, SPO2 100%. Outcome: Transferred to Medical Center, accompanied by daughter Responding HCP: EMTs on site, RN

Within minutes of receiving the injection I began to feel dizzy, a nursing provider took my bp approx 5-6 min after receiving the vaccination with a wrist cuff and it was 191/125 , she obtained a manual cuff and took it about 3- 5 min after the initial bp and it was 180/100. I felt more dizzy and laid down. I also had a rapid HR but did not take my pulse. The dizziness fluctuated and gradually cleared over 20-30 min. A third bp was 146/84 and a last bp approx 30min after the injection was 124/76 and I felt well enough to get up and walk.

Employee received Covid vqaccine, approx. 10 minutes later employee c/o dizziness b/p 178/90 Hr 64 02 sat 97%. Employuee states he is currently being treated by PCP for HTN. offered to call RRT and or transport to ED for evaluation. Employee refused. Recently started new b/p medication prior to leaving observation area employee reports dizziness resolved. b/p 161/93 HR 68 02 sat 97%. Employee to follow up with primary care physician

Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.

Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay

Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.

some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.

Felt faint, sat down with loss of consciousness for seconds x 2 ,estimated . She felt her heart rate was fast. B/P 98/48 - 87/40 HR 92 weak , per pt.

became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.

20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.

Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection

0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED

Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.

left arm pain at injection site, barely able to lift arm above shoulder without pain for first 2 days. 2 weeks later, still painful at injection site and general left deltoid area. no pain to touch, just with movements. pain with certain range of motion

Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.

12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.

Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.

2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness, severe headache, rapid heart rate, high blood pressure, tightness in chest and fatigue

Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.

Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"

pt states she woke up next after vax she woke up with cold symptoms, ie; stuffy nose, coughing, body aches and headache. Pt states she has intermittent dizziness.

Felt woozy like; felt like she's drunk. Pt denies tightness in chest, jaw pain or heaviness in chest. Treatment: Rest and water also referred to primary care clinic as she refused to go to the emergency room for further care. The pt was able to walk without assistance and stated she was fine.

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness

The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and when I removed the bandage noticed injection was near the shoulder and not in the mid deltoid area. The left arm/shoulder began to feel sore in the evening and was very sore the next day. Was unable to lift arm or move without pain. Over the next several days the severe pain decreased, but I continue to have pain in the arm, especially the bicep area. Range of motion is limited. Severe pain when trying to lift my arm from resting position while in bed. Severe pain when rotating arm inward. Pain occurs with certain movements.

Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.

chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.

19 hours post vaccination, sudden onset of dizziness and nausea, 1 episode of vomiting. Dizziness persisting.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA

I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.

woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.

Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea

Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.

Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours

patient reported generalized itching in her arms and legs as well as lightheadedness. She was given dephenhydramine 12.5mg/5l oral solution. Pt provided with water. Sx resolved. Pt was monitored for 30 minutes from symptom onset and 55 minutes from time of vaccine administration.

The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.

chest pain , lightheaded and palpitations . felt flushed and dizzy about 1 min after vaccination. felt better after observatrion

Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.

Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid. States she would like to reschedule because she was not feeling well. Reports she has not felt well since the first dose. States initially she felt dizzy and had a headache - the symptoms progressed to dizziness, headache unable to be relieved by medication, stomach pain and nausea. States she has consulted with PCP and lab tests will be ordered, she anticipates she will receive an order for a MRI of the brain. She also stated because of her symptoms she was considered by her work as a presumptive positive for Covid and was required to complete three Covid tests - all were negative. Encouraged patient to continue consulting with PCP and possibly an allergist. She will reschedule when she is feeling better.

Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue

Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to feel dizzy and vomit. Heart rate slightly elevated. Patient was taken to emergency room for further evaluation.

Approximately 3 hrs. after shot, I had extreme tiredness and slept for approximately 6 hours. I had a headache before and after sleep. The day after shot, I was still tired, had a headache, chills and a 100 degree fever. By evening, I was feeling fine. No headache, chills, or fever. 2 days after shot, I had a headache only. 3 days after shot, in the evening, I was very tired, had a headache, felt nauseous and dizzy. This did not last long. I went to bed and slept fine. Woke up feeling fine.

Feeling a little dizzy, woozy, tired at various times of the day, Also started itching the first night in bed and had a rash, It;s gone now. I don't know if the dizziness if from the vaccine or Vertigo?

About hrs after receiving injection- bad headache started - same as with the first injection. Not debilitating. Then extreme fatigue started, some minor dizziness. Not debilitating. I work in a cardiology office. Administrator advised me not to come in. Ended up sleeping for most of the next 18 hrs. No nausea, no elevated temp. Just unbelievable fatigue.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of vaccine at 1648. At 1700, pt reports slight dizziness 128/82, pulse ox 100, pulse 60. Denies respiratory distress, difficulty breathing. Urticaria absent. At 1715, 130/86, pulse ox 100, pulse 60 post oral fluids. Unchanged dizziness. Transferred to care. At care, pt presents with minimal lightheadedness/dizziness. Pt reports history of vertigo that has been triggered by fatigue. Pt thinks her reaction is due to a long day at work with difficult situations - she was very fatigued at the end of her shift, before she received her 2nd vaccine dose. Pt states she feels like she is about to get vertigo, but it never actually happens. Pt denies tongue swelling, lip swelling, or feeling like her throat is closing off. No rash, hives, itching. Pt discharged after about 30 minutes.

Patient reports feeling lightheaded after receiving her first dose of pfizer vaccine. Vital signs taken, BP 162/78, slightly elevated, no other concerns. Patient refused second set of vitals or any other care, refused any transport. Patient left by self.

Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.

Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours, monitored BP, monitored other symptoms (short naps, kept eyes closed as much as possible, minimal light

PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.

Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.

WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.

Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure

Approx. 10 minutes after vaccine administration, patient reported feelings of lightheaded ness. Upon assessment, vitals were normal. Patient was advised to follow with up PCP

Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) Light headedness 2) Increase heart rate 3) Hands tingling 4) Upper Lip numbness

Pt. reported dizziness for less than 2 minutes while waiting in observation after vaccine. She ate right before coming. She was given a snack and water and waited another 15 minutes. After 30 minutes she felt better. Pt. instructed to go to the ED with any worsening or new concerning symptos. Pt. verbalized understanding.

Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness

About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.

Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours

The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.

Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.

2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.

Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.

I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queezy, dizzy for about two days.

Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.

Received 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient Reporting feeling dizzy, HX of autonomic dyxreflexia. HX of vagal response with pain/anxiety stimuli. EMS response, fluids, BP 53/33 HR 46, O2 sats stable. Transported via EMS to ED. Received more normal saline fluids in ED.

Pt. voiced hx of difficulty breathing and rash after taking miralax.Pt states her PMD recommends she get CODID-19 vaccine, Our medical director consulted and agreed to give with 30 min wait time, near onsite paramedics. I vaccinated pt. next to paramedic. 10 minutes later pt. c/o dizziness, SOB, trouble breathing . Paramedics assumed care, Epi Pen administered. Ambulance called pt. soon felth better after O2 and Epi. No LOC. Pt. left in ambulance talking and thankful.

The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.

Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.

MEMBER BECAME DIZZY AFTER LEAVING THE OBSERVATION AREA. SHE WAS LEANING AGAIN WALL NEAR TRIAGE 1 AREA AND EMT OBSERVED HER, RETRIEVED WHEELCHAIR FROM TRIAGE 1 AND BROUGH HER FOR EVALUATION BACK TO TRIAGE 1. ON SITE CLINICAL LEAD AND PHYSICIAN ON SITE NOTIFIED. VITAL SITES ASSESSED AND REMAINED STABLE: 149/77 WITH HEART RATE OF 76. CONTINUED TO MONITOR WITH SYMPTOM RESOLUTION FOR A TOTAL OF 30 MINUTES. SHE WAS WHEELED TO FAMILY MEMBER AT CONCLUSION OF RECOVERY BY EMT.

The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".

Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.

Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Called her neuro doctor on 3-1-21 he said to take her to the eye doctor so I did. They told me her eyes are dry to put eye drops in. Called her neuro next day he told me to take her to the ER. They diagnosed her with Graves Disease and now she is showing symptoms of Graves Disease. She has never had any problem with her Thyroid. Had blood work done back on Jan 20th 2021

Guest completed post observation period and was check out when they became lightheaded and requested a chair to sit in. Guest reports lightheadedness is common for them as they are a cancer patient. Guest declined aid response and was moved in wheelchair to their personal vehicle to go home with their husband. No interventions beyond providing wheelchair. Guest reported improvement when sitting.

March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..

Dizziness, feeling disconnected, off. Happened immediately. Felt better the next day but have had the same feeling since the 3rd day. This is day seven.

No symptoms after the vaccination on the day of or the day after getting the vaccine. Two days after the vaccine, while at orthopedist (for a Rotator Cuff Surgery), I began to feel dizzy. I sat down for a few minutes, drank some water, and then resumed my therapy. After the first set of my 4th exercises I began to get dizzy, I sat down on the PT table, then laid down and fainted for about 1-2 seconds. My blood pressure plummeted to 60/?. EMT?s and an ambulance were called. I was given an IV and taken to hospital. In the ER, my blood pressure elevated to 205/121. (I think that was it.) I was given a cat scan, ekg, chest X-ray, blood tests, etc. All tests were normal except a very slight (by one number) magnesium level. I was admitted for observation and more tests where performed. My blood pressure remained high, but I had no more dizziness or syncope. I was given many more blood tests, imagining, ultrasound of heart, ultrasound of carotid arteries, ultrasound ?bubble test,? nuclear heart treadmill stress test. All tests were normal. The only change in my health that can be attributed to this episode is the Covid vaccine.

a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk/Noticed increase in her pain; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization and for autoimmune deficient. Medical history included sjogren's syndrome, rheumatoid arthritis from 2016 (reported as about 5 years ago), hip replacement, autoimmune deficient from 2007, and hip dislocates three times a year. Concomitant medication included tofacitinib ongoing citrate (XELJANZ XR, lot number: DR2042, expiration date: 31Jan2023), hydroxychloroquine, pregabalin (LYRICA), all three for unspecified indication. On 04Mar2021, the patient noticed increase in her pain. Such pain that she couldn't stand up or walk. The patient also had a little bit of hip and back pain on an unspecified date. The patient clarified that she has oxycodone as pain medication (med). The patient stated that she has too many medications that she has to take. Stated that her brain was dying. The patient also stated that she was doing fine and hasn't had pain like this. The patient did not know if it was an adverse reaction or what. The reporter seriousness for such pain she couldn't stand up or walk was assessed as disabling. The outcome of the events was unknown.; Sender's Comments: The causal association cannot be excluded between the reported events and vaccine use based on strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.

?Pulled? hamstring muscle for no reason. Unable to stand or bend leg for days On day 3 and finally improving. Did nothing different to strain the muscle other than get a vaccination. The only thing I did differently that day.

62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.

Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.

Date and time adverse event started: pt was vaccinated on 3/11/21, she felt fatigued from 3/12-3/17, on later developed nausea and dizziness on 3/19 until today. recommended to call pmd in am for possible evaluation. symptoms could be from other medical conditions.

Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.

I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.

Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.

Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.

2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.

Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.

Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up, Moved to a different chair from injection chair location. Passed out. Never vomited but become very nauseated. These symptoms all occurred within five minutes of the injection. Ran low grade fever all day on March 24 (day after).

Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept 5 hours. Spouse woke me up to eat. I was polite and took a few bites. Went to bed @ 10 pm. The next morning I woke in the fetal position and COULD NOT MOVE! Called husband for help. He lifted me to the sit up position by my rib cage. Very difficult to move for 4 days. Had Gammagard treatment on March 16. 2021. That was a mistake, I guess. I could not even think clearly enough to try to fill out this form.

Vertigo I Saw my doctor regarding vertigo and he prescribed Meclizine HCI 12.5 mg 2 times a day. He checked my ears and they were fine. I am going to Physical Therapy April 5 to be evaluated.

Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting. Excessive sweating chills and hot flashes But no fever. Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast. Ringing in ears.

Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.

Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure

Patient returned to the pod at 1219 after receiving her vaccine at 1201. pt states when she got to her car she began to feel dizzy and lightheaded. pt is also now having heart palpitations. no shortness of breath. no other symptoms. pt was assessed and vitals taken. bp is elevated at 189/120. all other vitals normal. additional rig was called for transport at 1243 due to rig on scene being dedicated to the standby. pt was further treated with an iv 20 gauge saline lock left forearm, and a 4 and 12 lead on the cardiac monitor. pts 12 lead showed a sinus rhythm with right bundle branch block. pt states she has no cardiac hx. kunkel medic 6 arrived at apprx 1255 and transported her to at 1300.

Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot. It is now 14-1/2 hours after the shot and I am still dizzy. I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications

difficulty breathing and slight light headiness. Took two puffs of inhaler. breathing a little better, light headiness still on going.

Skin flushed red on hands and arms, blotchy red spots on same.dizzy, felt like had a vise around head. Started sneezing and increased congestion. Within 15minutes of shot.

Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN

Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slept most of the afternoon, but was very nauseous could not stand up all day. In the evening started feeling slightly better and could walk to the bathroom unassisted.

onset of reaction 16 mins after injection: pt reported dizziness, sweating, throat irritation. No difficulty swallowing, no difficulty breathing. VSS, pt A&Ox4. MD at bedside, pt c/o lip and tongue numbness. MD ordered IM Benadryl 50mg. medication administered. EMS called for further observation and treatment. Pt left facility A&Ox4 in stable condition via EMS to ER.

Mild to Moderate Stomach Cramping began approximately 3 hrs after vaccine and were off and on for about 36 hrs. Also had mild Lightheadedness during the 36 hours.

On 3/20/21 pt started having diarrhea. Then she started getting chills, body aches, headache, dizziness and nauseated. Her back and legs are hurting. She has had these symptoms for over a week. She has been taking anti-diarrhea meds and Tylenol and Advil. Pt will contact her PCP.

After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The gout pain was so intense even after taking two pain pills, it kept me up all night. I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week. I was even getting up 2-3 times on some nights gasping to breathe.

I have felt unwell since I woke up on Saturday morning. Saturday - low fever, dizzy, general malaise Sunday - low fever, general malaise, stayed in bed Monday - low fever, gastrointestinal distress, very very tired Tuesday - very very tired

Patient felt light-headed within a few minutes post vaccination. She was transferred by EMT to the hospital for observation.

initially felt light-headed and dizziness, then had flu like symptoms lasting 24 hours. The lymphedema left axillary area lasting about 24 hours after first dose. Had a mammogram in March 2021 and it showed a spot on the left breast.

very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and muscles was a total nightmare; extreme weakness; very weak hand grip strength; Anorexia; unable to walk, stand up or sit down without max assist; unable to walk, stand up or sit down without max assist; Headache; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: BL9264) via an unspecified route of administration, administered in arm right on 10Feb2021 12:30 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no COVID prior to vaccination. Patient is not pregnant. No Known allergies. There were no concomitant medications. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 21Jan2021 11:00 AM for covid-19 immunisation at the age of 62 years old. Since 12Feb2021, patient was very sick, very painful muscles, joints, extreme weakness, very weak hand grip strength. Anorexia, unable to walk, stand up or sit down without max assist. Headache. Horrible. The pain in all of her joints and muscles was a total nightmare. Here it was nearly a month after, she was still quite painful and suffering with joint and muscle pain and weakness. These events resulted in physician office visit and emergency room visit and received treatment for the events, which included pain medication. Patient had COVID tested which included nasal swab (undated) and PCR on 16Feb2021 post vaccination, both results were unknown. Outcome of the events was not recovered.

I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in place. It was bad everywhere, but worse on my left side -- shoulder, elbow, wrist, hands, and knee. Also my right hand. I took ibuprofen and went back to bed. I wasn't able to do anything. I was extremely tired. I took ibuprofen throughout the day to manage the pain and slept much of the day. I also was coughing quite a lot. Today I feel mostly back to normal. Very little pain or stiffness in my left shoulder, elbow and wrist. Less coughing too.

Fell on floor landed on butt Couldn't get up Was still sitting on floor and fell over on my face All within 2 min

After 15 minutes of waiting and as we were leaving I started with a headache and had problems breathing. By the time we reached the car, I felt worse and went back inside to the paramedics. At that time I was having heart palpitations, problems breathing, BP was 194/120, felt lightheaded and dizzy. Was having problems with walking. The next day I woke up and my hands were curled up, hips were sore, body aches, hard to walk shuffling instead of lifting feet.

Foggy Head about 30 minutes post vaccine. Very dizzy and off center that night and the entire next day - about 24 hours. Was walking sideways at times Happening on and off since

Pfizer-BioNTech COVID- 19 Vaccine EUA: On leaving the facility, vaccine recipient stated she was "fatigued, dizzy, and fell into the bike rack" on her way to the car. National Guard placed her in a wheelchair and offered water Patient stated she felt fine upstairs but felt overwhelmed by the time she was downstairs. Her skin was cool, clammy, and pale. She was talking slowly. EMS was called when she stated her top of mouth and tongue were swelling and tingly. She was having difficulty speaking at a regular rate and was extremely lethargic. EMS called via 911 and patient was transported to Emergency Department. Patient was subsequently discharged to home from the emergency department.

dizziness, nausea, over 3-5 minutes that subsequently releived with water and rest. HR 50's-60's #21 advised to see doctor or other healthcare professional office/clinic. #21 advised to visit

Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman. Brain Fog occurred and slowed speech. Could not lift my arms or stand and needed to be placed in a wheelchair. It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.

62 y.o. female with a history of stroke in 2018. <30 minutes status post-Pfizer vaccination #1, she complains of numbness on the left side of the face, inability to move the left side of lips. Vital signs checked & normal by the EMS crew. Unable to smile left side of the face. Speech slightly slurred. Romberg negative. Possible cerebral ischemic event. Offered ambulance transport to ED; preferred to go by personal vehicle. Discharge to ED

Severe chills followed by vertigo presyncope and fainting. Could not stand. Fell when I fainted and landed very hard. It is now 1 p.m. and I am just now able to sit up in a chair. Last night, hands and feet were blocks of ice, couldn't stand to take temp. Barely able to get to bathroom, rocketed off walls and furniture. Extreme weakness in legs.

Systemic: Chills-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: During observation period, patient reported visual changes (seeing spots) and light headness. she temporary loss consciousness, therefore 911 was activated. While waiting for EMS to arrived, immunization pharmacist & technician checked patient's pulse and temperature. When EMS arrived, patient was coherent and EMS continued to provided care. I called patient earlier (around 8:15pm) to check on her status, patient reported feeling better. She received fluid & discharged from the hospital at 6pm

Dizziness, increased heart rate. BPs 190/117 (pulse 95), 169/98 (pulse 79). O2 sats 100%, 99%. Juice x 2, crackers.

Patient c/o dizziness and feeling lightheaded. Vitals were stable at 10:33 and 10:37. Patient refused wheelchair and demanded to leave after second set of vitals were taken.

Day 1 exhausted Day 2: Headache, sore throat, low fever Day 3: low fever abdominal pain on right side, Day 4: lightheaded /confusion

chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't sleep, left inner ear pain, blurred vision, pain in left elbow, numbness in left hand for 12 hours, shortness of breath, general weakness - adverse events have lasted over 48 hours - Advil taken with minimal reduction in symptoms

Approximately two to four minutes after vaccination, the patient's significant other stated the patient was dizzy. Nursing staff noted the patient was having jerking movements and patient became slumped over. 911 was called. Nursing staff obtained vitals and administered an Epi Pen 0.3 mg at 1415. Patient became alert and was able to communicate. Initial vials were pulse 52, Sp02 94%, and B/P 140/72. Vitals were taken again at 1419 and pulse 72, Sp02, 94, and B/P 112/70. Emergency medical crew arrived and assessed patient. Patient signed paperwork declining to go to the ED. Patient felt her condition had stablized. Patient was advised to contact her Primary Care Physician on Monday or call 911 STAT is any issues arise. Patient left the drive-up with her significant other. Patient was seen by her PCP on 4/6/2021.

3/24 - first Pfizer shot (days 1-7 no symptoms). 4/1 ? (day 8) severe headache woke me at 4am (pain 10), achy, dizzy, hurt to move, hot/chills. 4/2 - 4am headache, malaise, 99.3 fever. 2pm COVID PCR test (negative), 99.3 fever. 4/3 - 98.9 fever; little energy, headache (pain 6). 4/4 ? 4:30am ? woke from headache (pain 9.5), back of neck (pain 4), fever 99.9, right cheek redder than left cheek, 1pm to 5pm - headache increasing to bad (pain 9), intermittent sharp pain above left ear (pain 10 for 2 seconds) and tender scalp above left ear. 6pm - headache (pain 8), 99.8 fever, intermittent sharp pain at back of head where spine and skull meet (pain 10 for 2 seconds) and above left ear. 4/5 - 6am - headache (pain 6) and intermittent pain above left ear (pain 10 for 2 seconds), 10am - right cheek normal, left cheek deep red (gone by bedtime), 1:30 bright red cheeks, (left more). Energy all day. Intermittent sharp pain above left ear, scalp hurts above ear and top of head, one time pain shot down left side of neck. 11pm - pain worse, achy, back of neck hurts (can tilt forward, can't tilt much side to side), 98.3 temperature. COVID pharyngeal test (negative), blood work (no sign of infection), CT scan without contrast (normal, no sign of bleed). 4/6 - 8:15am - headache mostly top of head (pain 7), intermittent pain above left ear, very tender scalp (most top of head). 97.8 temperature. 8:30pm - headache (pain 7), bad intermittent pain above ear (pain 9, 2 sec), very sore tender scalp all day. 98.5 temperature, achy. 4/7 - 98.2 temp, headache (pain 6), intermittent sharp pain over left ear all day (pain 8, 1 second), painful scalp top of head. 4/8 ? AM - left cheek red (stayed all day), right cheek normal, headache (pain 3); PM ? sharp intermittent pain over left ear (pain 6, 2 seconds). 4/9 - headache (pain 1), temp 98.6, flushed cheeks.

Approximately 10 minutes after getting my 1st shot of the Pfizer Covid 19 vaccine I started to feel dizzy. I drank some water, alerted the vaccinator who asked me to stay 15 minutes later and gave me some crackers. After 15 minutes I felt better and left. Last evening I noticed some dizziness that went away. This morning I woke up I was achey, my arm was sore, dizzy and extremely fatigued. Luckily I work at home and have been able to rest. Advil has helped but I?m still very tired and arm is still sore

Woke with sever vertigo; bedroom was spinning. Was finally able to sit up and then sit on floor. Moving my head made the spinning worsen. Eventually (30 minutes) able to stand and then because nauseas and vomitted. Vertigo lessened. Approx 3 hours later felt somewhat better

Patient is a 62-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions before being vaccinated. At 3:34 pm, the patient received her first dose of Pfizer, (lot number EW0150, expires on 07/2021) on left deltoid, given by RN. The patient was able to give her verbal consent to receiving the Pfizer vaccine. RN, reports patient sounded "normal" and was responsive to all pre-vaccination questions. Patient reported mild anxiety to RN, immediately after being vaccinated. RN, followed the patient to the EMT observation area and assisted the patient to a zero-gravity chair. At 3:41 pm, while waiting in observation area, patient reported feeling "anxious" and "faint". EMT (Name), EMT (Name), EMT (Name) and RN, responded. At 3:41 pm, the patient became unresponsive to verbal stimulation. Her pupils were fixed and dilated. During this time, EMT took the patients vitals and found her BP to be 132/98 and HR 73 BPM. At 3:41 pm, RN called 9-1-1. The patient continued to be unresponsive for an additional 5 minutes with normal respirations of 17 per minute. At 3:45 pm, the patient jumped up out of the anti-gravity chair, screamed and proceeded to run down the hallway toward the patient restrooms. EMT followed the patient down the hall and RN followed. The patient collapsed to the floor and started to scream and convulse. While on the ground, EMT took the patient's blood pressure which was found to be 209/162 with a HR of 101 BPM. The patient was assisted to her feet by EMT (Name) and EMT (Name) and assisted her back to the anti-gravity chair at 3:47 pm. FD arrived on site at 3:48 pm and took over monitoring the patient's vital signs. The patient was A&Ox1 to self at 3:48 pm. She was unable to follow direction. Medical response assisted the patient to a stretcher chair with her arms and legs strapped to the chair. She left with EMS at 4:02 pm.

I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

The evening of 03/20/2021 the left side of my mouth began feeling numb and my left eye was drooping slightly. The morning of 03/21/2021 I could not close my left eye or the left side of my mouth. I went to the ER that morning and was diagnosed with Bells Palsy. I was given Prednisone and Acyclovir tablets. As of today, 04/10/2021 I still have very slight paralysis on the left side of my face.

2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and slept little till 8 am. Took 1 Tylenol at 8, and noon. Had a morning nap and afternoon nap over an hour and normally cannot nap. Took 2 Ibuprofen at 4pm. Aches in joints along with previous symptoms mentioned all day and subsided significantly by 8pm. Was unable to function normally and slept or laid down all day. Felt normal the next morning. Had no arm pain at injection sight at all this time.

First Vaccine Pfizer EN6206 Wednesday Night 3/17/21 Bumps on Throat, hard to swallow, tongue felt swollen and warm, Took Tylenol PM (has Benadryl in Tylenol) Thursday 3/18/21 Bumps on Throat, tongue felt swollen and warm, NO TASTE, Headache, Queasy Stomach, Lightheaded. Friday 3/19/21 Bumps on Throat, No Taste, Headache. Taste Returned Friday Night Saturday 3/20/21 Bumps on Throat, mild headache.

Day 2- started out fine, at 9am got bad headache, then started feeling very tired and dizzy, layed down woke up around 1pm started feeling nauseated ran a fever, stomach was hurting (whole abdomen) had diarrhea had no appetite could not even eat more than 1 bite of a dry bagel. Was so tired couldn't do anything but sleep. Day 3- same symptoms as above but no fever, stomach a little better. Finally at 8pm ate a banana and husband made me eggs. Took until almost 10pm to eat eggs. Day 4- felt much better but still tired and a little weak but was able to walk around house a little and had yogurt for lunch and was able to eat a regular dinner.

Lightheaded during the day, dizzy spells upon laying down and getting up, foggy headed. Started about 24 hours after shot.

Pt states feeling dizzy post-shot. Also complaining of tachycardia. Pt appears mildly anxious. SBP checked = 174. Patient states she has high blood pressure. HR checked 80, appears regular. Patient given benadryl.

has a chronic L lower leg inherited peripheral neuropathy, after injection 2 days later had a marked increase in pain and the pain also involves the entire L leg and hip. Treated with OTC analgesics, use of a cane, increased gabapentin dose. Pain today on 4/12 is improving

injection site pain tiredness headache muscle pain chills joint pain fever injection site swelling nausea feeling unwell swollen lymph nodes dizziness and weakness

Approx 12hrs after vaccination, and lasting approx. 36hrs: Fever, chills, sweating, muscle and joint pain, nausea, vomiting, diarrhea, severe headache, dizziness, weakness. Light headedness, fatigue and queasy stomach persisted from onset at 12 hours after vaccination until April 12, 2021.

Felt light headed 2 days bad fatigue and second day sweaty. Been 1 week today and I still feel very weak.I had the virus July 28th where I had green ruins flushing out of me for 1 week . A little cough and no appetite .weak for month and confused a little. Then tested positive for the antibodies. I heard the second shot can be worst and also if the had the virus so I don't think I want to get the second shot. I have a high immune system and never had the flu shot or get sick .I only have sinus that effects me in change of weather .I hardly take anything for thatc.

I started feeling ill the sixth day after hot cold then. Then on Monday I start getting severe stomach cramps and then I started having diarrhea and then vomiting Tuesday the 30th I was sick to my stomach all day long. Wednesday the 31st my son took me to the ER and they admitted me into the hospital. I was also wondering I need help paying for the hospital bill because I am on Social Security disability.

patient felt nausea and dizzy and was thinking of passing out but did not and was fine after observation

5 hr following receiving injection stated unable to raise arm; 1.5 days later noted lymph node pain under both ears--stopped after 2 days. 3.5 days lymph nodes under arm and breast area painful--lasted 2 days and stopped. After that had diarrhea for 2 days. Throughout the entire time noted above had heart palpitations and shortness of breath. She was advised at time of 2nd dose (4/14/21) was advised to contact PCP and share above information prior to getting 2nd dose.

artritis flare up in right foot. extreme pain, red hot spot and couldn't walk on foot at all .....also arthritis flare up in left hand extreme pain red hot spot and unable to us hand.

Pt. reports she initially had left arm pain after second dose of vaccine and then developed significant left arm/deltoid pain with ROM one week later that has not improved.

1st Covid vax 3/12/21; pt. had severe headache x 2 days helped w/Tylenol. 2nd vax 4/5/21; pt. had fatigue, body aches, muscle cramps in legs and lower back, improved in 1 week with increased water intake; also had vertigo lasting a week. She also is experiencing sweating day and night. States her hot flashes were under control until she had the 2nd vaccine. She called her PCP who advised Tylenol for aches and to increase water intake; also has taken AlkaSeltzer Plus Cold for 8 days with improvement of h/a and bodyache but pain returns when it wears off. States she still "doesn't feel well" and may go to urgent care for variant testing soon and was urged to seek care as she feels the need.

Disequilibrium one week after vaccine- dizziness upon waking throughout the day until bedtime; Day 2 dizziness continues with headache in the left temple area

Dizziness, numbness and nausea. 12 lead ECG, 18g IV, Blood Glucose, Vitals stable, 4mg of Zofran, transported to Hospital

Pfizer-BioNTech COVID-19 Vaccine EUA Shaky and slightly dizzy Slight weakness and lightheadedness Began about two hours after receiving injection, and lasted the rest of the day

4/13-c/o abdominal pain, headache, lightheadedness, nausea since 4/8/21 evening. Caller reports blood sugar was "normal" yesterday but has not checked it yet today. Called her PCP and they recommended she get a Covid test. Recommended to caller to monitor blood sugars, increase fluid inake, OTC pain relievers as needed. Caller verbalizes understanding. She also asked if symptoms could be r/t taking melatonin last night. She takes it PRN. Informed caller symptoms may be related to a combination of factors.

Started on April 1 I was hurting in m y grove area, Friday April 2 I went to the clinic I had my shot at. They did a chest extra to make sure I didn?t, have a blood clot. When home on Saturday I could hardly walk and get up on my own. It would rotate to both hands and wrist couldn?t bend my fingers. Went to Dr took labs if need contact physian. Went to ER twice and gave me a steroid shot. Gave me pain medicine and medpack

Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.

March 31 - one hour after shot numbness and tingling in left forearm for 30 minutes or so. April 1 - 9 pm severe muscle pain, migraines, nausea, dizziness, neck pain on both sides. These continued until Monday am April 5. Then the night of April 5th, neck pain on both sides and then under my left ear, down my left neck and all across to my left shoulder, large patch of fluid under the skin and my left underarm is extremely swollen with fluid and a lump in my armpit. April 16th - still have all this fluid and I have a dr appointment on Monday, April 19th to ensure I don't have an infection. I have not had COVID 19 nor have I been exposed. Been very sheltered in place at home since March 2020.

* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went to ER. Transferred to clinic in. Admitted to clinic on 4/5/21: - Test: Ultrasound, Xray, Lab Tests, Electrocardiogram - Outcome: Pericardial enhancement adjacent to the left ventricle with no effusion - Treatment: Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach

2 days after the injection i started getting real dizzy, i had to call someone cause i nearly passed out. they took me back to the office and let me sit there till someone came to relieve me. then i went home. that was on Friday Jan 29, 2021. I stayed out of work for 3days, went back to work on Mon Feb 1, 2021, still being dizzy i continued working till my days off on Wed Feb 3 and Thurs Feb 4,2021. went back to work Friday Feb 5,2021. had to leave work again because of severe dizzines. Called immediately to see if i could get an appointment and got one Saturday Feb 6,2021. then tried again to return to work again on a MondayFeb 8, 2021, worked through with vertigo again till days off Wed Thurs Feb 10 & 11,2021. Tried to work again same thing on Fri Feb 12, 2021. Left work again and been out ever since.

INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARDIA,THROAT TIGHTENING,DIZZINESS ON STANDING,HEADACHE,FEVER,NAUSEA,UNBEARABLE MUSCLE PAIN,WEAKNESS ALL OVER BODY STILL TODAY,PAIN BETWEEN AXILLA AND LEFT BREAST,DECREASED APPETITE,I GET TIRED QUICKLY,AND EVEN TODAY,,NAUSEA,DIZZINESS BODILY WEAKNESS,HEADACHE,AND I STILL HAVE INFLAMMATION....I THOUGHT I WOULD DIE!!!!,THE ADVERSE REACTION WAS EXTREMELY HORRIBLE

HOT ZINGING FEELING RIGHT ARM, SHOULDER AND CALF ONSET Immediate / DURATION 30 minutes INJECTION SITE PAIN day 2 / 2 days TIREDNESS day 2/ ONGOING SEVERE HEADACHE AT PREVIOUS CONCUSSION SITE day 3/ ONGOING but no longer severe CHILLS day 2 / 2 days SEVERE JOINT PAIN AT DAMAGED JOINTS day 2 / 2 days LOW GRADE FEVER day 2 / 2 days VERTIGO/NAUSEA/VOMITING day 2 / 2 days (I LOST 4 LBS) DIZZINESS Day 2 / ONGOING FEELING GENERALLY UNWELL day 2 / 2 days FACIAL PALSY RIGHT SIDE INLCUDING EYE SOCKET day 1 / BAD ON DAY 1, LESSENING EACH DAY BLURRY VISION RIGHT EYE Immediately / ONGOING INTERMITTENT HYPERTENSION Day 3 / Lasted all night. I couldn't sleep. Was sort of vibrating. Got up to 168/107. Was down to 116/88. Now bouncing around and up again at 150/96. My norm is 110/70ish. When I got the shot I had to sit with an EMT for 90 minutes because of the facial palsy. Then I was massively sick for 3 days. Vertigo, dizziness, and vomiting were the worst. Now the pain at concussion site and continuing dizziness is lousy, plus the BP increase started last night and is bouncing around. Maybe it will settle down like all the rest of the side effects. Seemed like each day brought on new side effects and they last from 12 to 48 hours.

3/18/2021 - Lot ER2613: 11:50 am First Dosage Beginning the same day as the vaccination, I experienced severe Vertigo for 3 days. 4/14/2021 - Lot ER8735: 12:45 pm. Second Dosage Within 5 minutes of receiving the Vaccination, I experienced Shortness of Breath, Dizziness & Numbness on my Left side. There was an EMT present who brought me to a cot, took my Blood Pressure (164/104 ) and Pulse (48). After 20-30 minutes of No Improvement, I was transported to the hospital & was discharged approx. 6:15 pm with Symptom improvements.

Patient c/o feeling warm on left-side, legs shaking upon standing, balance issues per patient report. Shortly after, patient c/o of itching. BP 198/77. Patient transferred for further observation.

Client received the 1st COVID vaccine of Pfizer (lot # EW0171 and expiration date 4/25/21) at approximately 2:16pm . Client reported to EMT that as she was leaving the waiting room and "stood up she felt dizzy." Client was alert and oriented X 4 and sitting in a chair near EMT station when Nurse arrived. At 2:31PM vitals were oxygen:96%, blood pressure:132/88 and pulse:88. Transfer client to gravity chair. Client reports blurred vision, a slight headache and tingling in her right arm although she received the shot in her left arm. At 2:36 pm vitals were oxygen:96%, blood pressure:134/88 and pulse:91. At this time client reports dizziness is subsiding, arm tingling has resolved but now she is getting tingling in her left leg, sensation and movement intact. Client reports feeling weak and that her left wrist is also tingling. Offer client water. At 2:41PM oxygen:97%, blood pressure:136/86 and pulse:88. Client reports tingling in lower left leg and by left thumb. At 2:46pm client reports right foot tingling on the top. At 2:51PM oxygen:96%, blood pressure:134/86 and pulse:88. Client reports dizziness has subsided and that the tingling in her left leg is coming and going but right foot tingling has resolved. At 3:01pm vitals were oxygen:96%, blood pressure:134/86 and pulse:85 and reports that tingling has improved. Client reports having a history of asthma and environmental allergies. Client takes montelukast (singulair), wixela, ventolin, proventil, loratadine, and vitamins. Client was provided ER precautions and to follow up with provider. Client left facility with a steady gait at 3:04PM.

The expected soreness in my arm developed throughout the afternoon of the morning (Friday) I had the shot along with a fever. I had fever and chills all night - my teeth chattered all night. The fever continued throughout Saturday and my nose was congested. My chest felt tight. Of most concern my neck was so stiff Saturday and Sunday that I could not move it or turn it in the slightest. The pain radiated down through the shoulders but no further. The overwhelming fatigue I had felt when I had Covid in late March-early April was back. I could not stand long without having to sit down and walking around made me feel breathless. I stayed in bed all weekend. The fever broke Sunday night and by Monday morning I could move my neck, but it was very tender and I did not have my normal range of motion. My congestion turned into a runny nose on Monday which cleared on Tuesday. By Tuesday my energy level was close to normal and I had full range of neck motion, although still tender. I never had a headache at any point over those four days.

Had severe arm pain which I medicated with Tylenol which became significant body aches overnight. Caused difficulty sleeping even with Tylenol. Continued through the next day but subsided in the evening. Also experienced fatigue and dizziness that same day which also both subsided.

12./2020:seen by PCP for PE; found to have Hidradenitis suppertiva under arms,breasts; on (3) rounds 1st inj of Pfizer/FN6207 given subqQ at 11:00am on 3.23.21; Right upper arm hurt at needle site. 2nd Inj of Pfizer/EW0150 given subQ at 10:55am on 4.13.21; right arm; no pain at site. Next day, 4.14.2021 woke-up @ 6:00am like a train had just hit my body. Very unsteady on feet, nauseas, no appetite, up a few hrs, took a Deuxis 800/26mg with some relief. 4.15.2021 woke up @ 7am feeling alittle better, able to function more than day prior. 4.17.21 eyelids/ bilateral inner canthus(s) became swollen, reddened. 4.19.21: email sent to PCP with (2) pics of my eyes, still swollen and red .

Approximately two days after receiving the second dose of the vaccine. my left arm and shoulder became very sore. I have trouble lifting it and cannot lay on that side without pain.

Vertigo, pain in toes, feeling of fullness but different than one with have with a cold starting about 4 days after the second injection. I had been diagnosed with BPPV in 2007 by (EENT) following what was suspected as meningitis. I was deaf initially and after a year of prednisone treatment recovered all hearing but the vertigo and tinnitus remained. The vertigo stopped after physical therapy and the tinnitus dropped from a 10 to a 4 at that time. After the second dose of the vaccine the tinnitus went back to a 7 and the vertigo was similar to experienced in 2007. The tinnitus is now is back to 4-5. The pain in the toes started about the same time. I have never had that type of severe, sudden jabbing type before in my toes and it affected three of them on either foot off and on for several days. It has also stopped. I disregarded the fullness thinking maybe springtime pollen but I don't have allergies and the tinnitus was markedly increased. I didn't seek medical advice since I hadn't been aware of any adverse affects of the vaccine like this and thought it must be just an odd happening and since it went away I was okay. My husband read on NPR today that my symptoms were reported in rare cases and we looked at the date the vaccine was given and thought perhaps they might be related.

Severe Headache, Vomiting, high fever over 103 (my base temp is always 96.5-97)complete body aches, chills, lightheadedness tiredness. Headache better after 24 hrs, but now 4/24 it is back. The fever went down to 100 but today is inching back up. Still achy and extremely tired and I have lightheadedness and fainted today. Off and On I feel chest pain, but it could be anxiety.

Herpes Simplex virus of the eye. Very painful and still not cleared. Began on day 6 after second vaccine. Had this 16 years ago and never again so I assume it is the vaccine or process that reactivated the virus in my eye. Also had lameness for a day, sore arm for 3 days vs the soreness I had for only 8 hrs after the first shot, lower legs burned for about a day

cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.

3:01 - Felt heart racing, called for help, fell unconcious. Upon regaining conciousness, there were 2 people attending to me - BP was very low, heart was racing. I was not able to get up. Had a feeling of extreme 'popping' in my lower arms. Was not able to move. Ambulance was called as BP was low and HR was not coming down. Attendants took me to the ER at 3:18 as I was still not recovered. Started IV in ambulance. Heart was reading PAC also. BP came up to 66. another litre of fluid at the ER. by 6:00 pm BP was 110/79 and I was dismissed.

immediately started with tingling on tops of both feet particular on left foot/ tingling in toes; I am having trouble with my left foot; it's a sensation of tingling that is weird; tripping periodically; It doesn't hurt but it could hurt/pain threshold/foot; it is like I have drop foot / Like foot drop; This is a spontaneous report from two contactable consumers (patient and her husband). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENS208 (patient's husband also reported that the 3rd digit could be a 6 or an 8, patient added that it was EN8208 but her husband stated he was less confident)), via an unspecified route of administration, administered in Left Arm (also reported as left shoulder) on 11Mar2021 at 15:00 (at the age of 62-year-old) at single dose for there's a pandemic going on. Medical history included she walked everyday and exercise a minimum of 45 min/day, for years, 20 years; high blood pressure; her condition, there was something in her esophagus and there was a problem; had a problem with her parathyroid and they removed it, there were 4 nodes and they took 2 and there were still 2. Patient's mother is 99 and had an accident. Ongoing concomitant medications included lisinopril from an unspecified date (reported as has been on 10 years or so, so a long time) for high blood pressure; colecalciferol (VITAMIN D) from an unspecified date (reported as has been on for about 3 years) as she had a problem with her parathyroid and they removed it; alendronate sodium (ALENDRONATE) from an unspecified date (reported as has been on for approximately 3 years) for bones and back to make sure she has enough calcium in her bones; pantoprazole from an unspecified date (reported as has been on around 3 years but she does not remember, it has been about three years) for her condition, there is something in her esophagus. Despite all of these medications she is healthy. Patient reported that she did not know if this was vaccine related or not, but the timing was. She got the vaccine on 11Mar2021, and immediately started with tingling on tops of both feet particular on left foot on the way home, which was side she got vaccinated on. She got tingling immediately following vaccination on 11Mar2021, and it's worse now but stable, not getting worse, it was like she have drop foot, sort of like that in 2021, she had to remember to lift her foot. She exercise. She walked everyday and exercise a minimum of 45 min/day, for years, 20 years. She had been walking and now she was having trouble with her left foot in 2021. Tingling on feet started right away, she drove back from vaccination site about an hour. She was able to drive and walk, it's not stopping her life she was tripping periodically mostly on her left foot in 2021, because she was not always conscious of lifting her foot. It's not painful, it's a sensation of tingling that is weird, it did not hurt but it could hurt, if it got worse it could be in the pain threshold, it's just in the annoying threshold in 2021. Like foot drop, like nerve damage on the top of left foot in 2021. She thought that if she didn't have a vaccine, she would say it felt like a nerve damage sort of thing, in both feet but predominantly in left one giving her trouble. Patient's husband added that the tingling was not excessively painful, it easy for him to say it was not painful. Tingling in toes was primarily on the left. She added that the tingling was not debilitating but it was just her husband she did not know if it had anything to do with the covid19 vaccine. No previous immunizations with suspect product. No additional vaccines administered same date. No AE required visit to Physician's Office or Emergency Room. No prior vaccination within 4 weeks. Family medical history relevant to AE was none. No investigation assessment for this, she had a physical next week which was just standard and just a standard battery of tests. Therapeutic measures were taken as result of all events included lifting her foot. The outcome of the event tingling was not recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

Extreme joint pain, knee & hip, affecting ability to function in normal activities of daily living, mobility, etc. And also requiring opioid pain medication daily in order to treat/manage debilitating joint pain.

Client received Vaccine at 0843. at 0953 client sitting in observation area and stated felt "dizzy." At 0954 assisted client to walk to lie down supine on the bench. Vitals taken at 0955: BP 170/90, RR 20, bpm 80 (pulse rhythmic and regular with palpitation). Clt stated continues to feel dizzy, with "a little nausea," denies blurry vision, denies vomiting, skin dry and appropriate color. elevated legs at 0958. At 0959 clt reports dizziness and nausea are gone, "feeling better." 0902 Vitals recheck: 170/100, 18 RR, 80 bpm lying down. 0906 PHN's assisted client to sit up. States dizziness returned. Called 9-1-1 at 0909, administered 50 mg of Benadryl PO to client while sitting up. PHN's assessed clt to lie back down. 0915 vitals recheck: BP 160/90, RR 20, 60 bpm. 0918 EMS on scene and resumed care. Per EMS: 0925 clt signed AMA, vitals stable, c/o continued mild dizziness. Clt not observed falling over and able to sit holding onto walker, states "felt better." Clt's partner will stay with her in hotel room to monitor. PHN's educated f/u with PMD in 24 hours, and s/s when to call 9-1-1. 0930 clt stood up with walker and walked away with steady gait.

Mild headache in morning after vaccine, progressed to moderate headache with body aches, fever (100 F) and lightheadedness in midafternoon. Symptoms remained into the night and fever rose to 101 F. Symptoms resolved overnight but headache and fever (100) returned for 3-4 hours in the afternoon of April 23.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe

1. Runny nose & sore throat 2. Entire aches & pains with chills 3. Fever developed in evening - Normal temp is 98.2 F Slowly raised to 98.8 F Next day 1. Dry Eyes 2. Mild ear ache in both ears 3. Fever developed in afternoon to 100.5. 4. Who body aching all day with shooting pain from right leg and shooting pain from right knee. 5. Pin point headache above eye - right frontal lobe Long Term - Shoulders, hips and knee joints inflammed. Hard to walk.

pt says 45 minutes after getting the vax her blood pressure spiked to 220/119. She BP is normally 137 or 124 over 76 or 74. She was monitored for over 3 hours. Her balance was off the entire day. She had weakness in her left arm. She went home with headache, runny nose, and coughing. She took her migraine medicine Ubrelby for her headache. This did not help just made her sick to her stomach. Pt says the all of the symptoms are better but she has a constant migraine. Pt has contacted her doctors. They sent her a package of steroids medication to take which she has not started taking yet. She has reached out to her doctors before starting meds due to her health conditions.

on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extremely light-headed; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 19Jan2021 06:45 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes (well controlled), and fatty liver disease. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; olmesartan medoxomil (BENICAR); and omeprazole (PRILOSEC); and vitamin B complex. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Dec2020 06:30 (Batch/Lot Number: EL1284) at the age of 62 years old as single dose for COVID-19 immunisation. On 20Jan2021 09:15, the patient experienced felt faint and extremely light-headed and on the verge of fainting. The patient laid down and then took her blood pressure. It was 82/48. Her blood pressure remained low throughout the day and did not return completely to normal until 3 days later. No treatment was received for the events. Outcome of the blood pressure was 82/48/blood pressure remained low was recovered on 23Jan2021 while of the remaining events was recovered on 2021.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of an association of the suspect drug administration with the reported events, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Felt light headed and dizzy for greater than 30 mins. Symptoms weren't not subsiding. EMS was called and was transported to a local hospital via ambulance.

Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chills, joint pain, fever, injection site swollen, hot, and red size of 50 cent piece

Symptoms: Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16.21) She fell the first evening (4.16.21) after losing her balance. She denies significant dizziness, weakness or numbness. She fell again yesterday (4.27.21). (called nurse triage line to report on 4.28.21) She also reports worsening of her urinary incontinence and isn't sure if its related. She reports a headache only because she fell hit her head when she fell. Balance issues-recent fall twice concern seeking medical advice Noticed no balance control Noticed increased of dreams of falling while sleeping first fall on same day of vaccine 7:30pm second fall yesterday -around 10am Symptom duration: couple days Recommended ED or Urgent Care - no follow up or visit by patient at this time of reporting (evening 4.28)

I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Fatigue, Non-stop Headache, Chills, Muscle pain, injection site pain - in bed incapacitated for 3 days

HUSBAND REPORTED THAT PATIENT FELT DIZINESS AND VERTIGO RIGHT AFTER VACCINATION, LASTING FOR OVER A WEEK. HE DID REPORT THAT IT IS GETTING BETTER. PATIENT ALSO REPORTS HIVES WITH ONSET A WEEK AFTER VACCINATION. HIVES ARE DESCRIBED TO BE SMALL, INDIVDUAL DOTS LOCATED ON THE BACK AND ON ARMS. PATIENT OOK ALLEGRA AND TYLENOL PM (CONTAINING DIPHENHYDRAMINE) WITH SOME RELIEF.

1st dose of Pfizer at 08:17 and was walked to observation area. It was noted by EMT on-site that she stated at the end of her observation time that she was very light headed and the room was spinning. She did not feel comfortable walking at the end of her observation time. At 08:46, call placed to outside EMS by EMT on-site had initiated direct transport to ED per patient's request. Patient stated she just flew home from Florida last night so she is wondering if she may be dehydrated or maybe even anxious about the shot. Patient stated she would feel better being monitored in the ED to make sure she is fine. History of: Anaphylaxis to Tetanus Toxoid Nursing Assessment: Airway: Open Breathing: Spontaneous Circulation: Pulse present, Mentation: Alert, Oriented x 3 Skin: Normal Patient monitored., Vital signs obtained and recorded. and Oxygen saturation level obtained. 0853: BP 181/98, HR 61, RR 14, non-labored 0855: BP 178/103, HR 70, RR 16, non-labored 0858: BP 174/100, HR 58, RR 16, non-labored Oxygen saturation was 99-100% on room air and was continually monitored until ambulance arrival. Patient was given water and was able to walk independently with stand-by assistance to get onto ambulance stretcher despite stating she was still dizzy and the room was spinning. She was transported to the emergency department via ambulance at 0910.

blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.

My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.

felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.

She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.

Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.

I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl. On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.

Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

right foot is in a lot of pain feels like its broken, barely can walk; right foot is in a lot of pain feels like its broken, barely can walk; This is a spontaneous report from a contactable consumer (the patient). This 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in in the right arm in Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. The patient's medical history and concomitant medications were not reported. The patient previously had blisters on the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in in the right arm in Mar2021 at 14:30 (at the age of 62-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 03:00 AM the patient experienced her right foot is in a lot of pain feels like its broken, barely can walk. She considered these events resulted in disability. No treatment was received for the adverse events. The clinical outcomes of the "right foot is in a lot of pain feels like its broken, barely can walk" were resolving as of 24Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

green stools; difficulty breathing; nausea; headache; dizzeyness; loss of appetite; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: paa156051), dose 1 via an unspecified route of administration, in Arm Left, on 27Jan2021 12:30pm as single dose for covid-19 immunisation. Vacination facility was Other. Medical history included High blood pressure, Low potassium and High cholesterol. The patient had no allergies. Concomitant medication's included Lisinopril, potassium and simvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient previously reported her adverse events but forgot to add that on 29Jan2021 at 06:00pm she have had green stools since the vaccine along with the 3 episodes of difficulty breathing, nausea headache dizzeyness and loss of appetite this was from wed of injection until friday 9 days later. The patient was terrified of receiving the second dose because these symptoms happened on the 3rd day and later. If she does not take the second dose what are my chances of surviving the virus if she should come down with it. She tried calling and was on hold for 4 hours and no one picked up. Events resulted in emergency room. The patient underwent lab tests and procedures after vaccination which included COVID-19 (sars-cov-2) test: negative on 05Feb2021. Patient did not received any treatment for the events. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events. Follow-up attempts are completed. Information about lot/batch number cannot obtained.

To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

Uncontrollable vomiting and diarrhea resulting in severe dehydration and inability to maintain electrolytes with no diagnosable infection to blame. Bed sore from inabilty to move for 14 days until transported by ems.

She got her vaccine, and immediately had a sodium taste in her mouth. She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth. Her Meniere's medicine is not helping at all, and she is not able to drive. She is really weak and went to the ER twice and they did some chest X-rays that were fine. They took blood and told her that her sodium was fine, and she feels that was wrong it should be low. She has a lot of problems with sodium. The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment. They told her that it was something like her inhaler, and didn't give her anything else. She was then discharged after 3 hours. She is too weak to walk so is in a wheelchair. She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD. The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired. She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair. She has an APT on Tuesday with a pulmonary specialist.

Sore arm where injection was given; body aches; muscle aches; headache; dizziness; felt very warm but had normal temp; Stiffness in legs; Slightly swollen arm; severe fatigue; numb toes and left leg-foot below the knee; diaphoresis; This is a spontaneous report from a contactable Nurse (patient herself). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on Arm Left on 26Jan2021 as 2nd dose, single for COVID-19 immunisation. Medical history included multiple sclerosis. Allergies to medications, food, or other products was reported as none. Concomitant medications were not reported. The patient historical vaccine includes first dose of BNT162B (lot number: EL0140) on 30Dec2020 (at the age of 62-year-old) on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:30, the patient experienced sore arm where injection was given, body aches, muscle aches, headache, dizziness, felt very warm but had normal temp, stiffness in legs, slightly swollen arm, severe fatigue, numb toes and left leg-foot below the knee and diaphoresis. The patient was not diagnose with COVID-19 before vaccination and it is unknown if the patient diagnose with COVID-19 after the vaccination. Therapeutic measures were taken as a result of the events with Aleve every 8hrs. x2 and 1 Tylenol x1. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected. Information about lot/batch number cannot be obtained.

This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

severe arm pain; Nausea; Dizziness; klebsiella pneumoniae, 50,000 to 100,000 cfu; Headache; Urine retention; blood and blood clots in her urine; blood and blood clots in her urine; tore or messed up a ligament in her hand; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in arm right on 31Mar2021 (at the age of 62-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included fibromyalgia from 1996 and ongoing, allergies from 1981 and ongoing, hypothyroidism and is pre-diabetic from 2012 and ongoing, Lyme disease from an unknown date and unknown if ongoing, concussion from Sep2019 to an unknown date, post-concussion syndrome from Sep2019 and ongoing , seasonal, food and chemical allergies from an unknown date and unknown if ongoing and had wisdom teeth extracted on an unknown date. The patient's concomitant medications were not reported. The patient previously took nalbuphine hydrochloride (NUBAIN) and experienced anaphylaxis. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6206), administered in right arm on 10Mar2021 for COVID-19 immunisation and experienced Face and ears became very flushed, red, and itchy, Headache, headache was more like a migraine/felt like a migraine, but worse, Post concussion syndrome was retriggered, not eating well and had lost some weight, feeling more worn out, she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction, flu like symptoms, achiness all over, pelvic pain and pressure, some burning during urination, did not have the energy level and stamina that she used to, blood in her urine and clots, she was not able to release the urine (urine retention), Nausea and Dizziness. About a week after receiving the second dose of the Covid-19 vaccine on 31Mar2021, she noticed the feeling again of retaining the urine. She was not swollen or anything and immediately went with increased fluids. The urine retention was not as severe at that point. It really showed up and intensified quickly with groin pain, pelvic pain, abdominal pain, and some back pain. She woke up the next morning after being doubled over in pain the night before and there was so much blood in her urine that she couldn't see any urine. Her urine was the darkest burgundy and the color of the darkest wine. She did not have anything in her urine the night before when she was doubled over in pain. She was increasing fluids and even drinking Propel for the electrolytes to make sure she was not making things worse. She woke up around 5 AM and felt so sick to her stomach. She had nausea the night before, but she was really nauseated the morning that she discovered blood in her urine. She woke up with severe nausea last Friday, 30Apr2021. Her doctor performed a urine culture. The urine culture returned positive for Klebsiella Pneumoniae with 50,000 to 100,000 CFU/mL on 30Apr2021. She does not have the urine culture results from her first doctor visit. Her friend is an RN that is administering the Covid-19 vaccine, was talking to company representatives and told the caller that she needed to call company to make a report and see if anyone else has experienced the same adverse events. Urinary retention came back in Apr2021 following her second dose of the Covid-19 vaccine on 31Mar2021. She can really go to the bathroom, but she is still feeling the abdominal and pelvic pressure as well as some burning and pain. Her symptoms are improving but not enough. It feels like she always has a full bladder still. She tore or messed up a ligament in her hand and she has been going to occupational therapy. She can't seem to be able to handle a pain level like she used to. It seems like pain is triggering her feelings of nausea and dizziness. Her body is not doing things well right now. The day before, of, and after getting the Covid-19 vaccine, someone suggested taking electrolytes before the second dose of the Covid-19 vaccine, so she drank Powerade. She was expecting the symptoms following the second dose of the Covid-19 vaccine to be a lot worse and they were a walk in the park in comparison. She had a mild headache the first day, 31Mar2021. She woke up in the morning of 01Apr2021 and her headache was gone. Following the second dose of the Covid-19 vaccine, she had severe arm pain. It felt like she was walking around with someone constantly punching her. She was moving her arm all around trying to get it to stop hurting. She saw blood and blood clots in her urine for over 24 hours. The blood and clots were lessening over the 24-hour time period. She probably saw in a 2-hour period at least 60 clots about the size of a quarter to a half dollar. The pain was excruciating. She was taking Phenazopyridine but is still feeling a sense of urgency, burning, and sometimes pain during urination. Her doctor did give her a prescription for phenazopyridine, but it was cheaper for her to buy over the counter and take the same dosage. She has been taking generic Macrobid, Nitrofurantoin Mono, 100 mg twice daily. It was dispensed in a pharmacy bottle. She is seeing a urogynecologist tomorrow, 06May2021. The patient underwent lab tests and procedures which included culture urine: unknown cfu on 26Mar2021 and culture urine: klebsiella pneumoniae, 50,000 to 100,000 cfu on 30Apr2021. The outcome of the event Headache was recovered on 01Apr2021 while of the rest was unknown. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Approximately 5 minutes after shot was administered into my left upper arm, as I sat down to wait my 15 minutes as required, I started to feel a racing heart, lightheaded, shaky, nauseous and strange sensation in my body. I was with my mother and my husband. My husband noticed I was struggling and called over the paramedic on staff. He came over and asked me questions, as to what I was feeling, he brought over a bottle water and asked if I wanted some Cola for the nausea, apparently it helps with nausea. At first I didn't want it, then I ended up taking a few sips. The entire episode lasted approximately 30-35 minutes, and I felt my heartrate returning to normal, however, I continued to feel out of sorts, shaky. Upon returning home, the entire evening of the day in question, I felt a heaviness in my head, ache over my eyes, then my body continued to feel strange, I was very tired, and of course, my arm began aching, I barely slept through the night, feeling strange sensations in my body, aching arm, and headache, nauseated. I had taken Tylenol after getting home from the vaccine shot. I finally got what I remember, maybe 2 hours of sleep, waking up to go to the bathroom, and my legs felt like cement! I could barely walk! Pain was radiating up the back of my legs, thighs, and buttocks. I held myself along the wall to the bathroom and could barely bend. After using the bathroom, I once again felt a tremendous heaviness, cement-like legs, barely making it back to the bed. Throughout the entire day I could barely walk, severe muscle spasms lower back, thighs stiffness, down the back of legs, severe pain. I contacted my doctor, told him of what was happening and he stated not to go back for the 2nd shot due to my issues with the 1st. This has been ongoing since April 28, 2021, today is May 24, 2021 almost one month later and I am no better. Although I have had Fibromyalgia for several years and Chronic Fatigue Syndrome, since the vaccine, it has triggered a complete relapse of my condition, making it unbearable, painful. I have been living on pain meds, and icing/heating on and off. Now requiring physical therapy.

Five days after the second COVID dose I experienced what I thought was motion disturbances similar to a head concussion (week long symptoms) I had six months ago. When I looked into what brain fog was with the vaccine it was very evident that was what was going on. I actually did not realize how bad it was until much later when it cleared. Difficulty focusing and having to repeat processing events that has never happened before. Difficulty sitting and following conversation after an hour need to get up and leave. Still some motion dizziness when turning head fast or downward such as putting on shoes.

felt warm in head and down body then developed palpitations and lightheadedness which resolved within 5 mnutes

Early 3/26/21, I experienced low grade fever, chills, and shaking. About 9 hours later, I became light-headed and fainted. I broke my left wrist on a coffee table after losing consciousness on the way down. Wrist was in splint for 4 weeks. 8 weeks later I am still receiving occupational therapy to regain motility/strength.

uncommon rectal bleeding and extreme diahrrea; Heart palpitations; lightheaded; uncommon rectal bleeding and extreme diahrrea; vomiting; legs and arms rash; This is a spontaneous report from contactable consumer (patient). A 62-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration, administered in the left arm (deltoid) on 19Apr2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included lisinopril for an unspecified indication, start and stop date were not reported; levothyroxine sodium for an unspecified indication, start and stop date were not reported; furosemide for an unspecified indication, start and stop date were not reported; valproate semisodium (DIVALPROEX) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration, administered in the left arm (deltoid) on 22Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 01 :00 AM, the patient experienced uncommon rectal bleeding (medically significant) and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash. The events resulted in Emergency room/department or urgent care visit. The patient was given unspecified I.V. drip, and unspecified meds and underwent CAT scan, specimens, and EKG, no results provided. The outcome of the events, uncommon rectal bleeding and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash was unknown.

Dizziness; Hypertension; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6198) via an unspecified route in the left arm on 22Feb2021 at 12:00 PM (at the age of 62-years-old), as a second single dose for COVID-19 immunization. The patient's medical history included hypertension, depression and anxiety. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril HCTZ (hydrochlorothiazide) and fluoxetine (PROZAC) for unknown indications received on unknown dates. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN5318), via an unspecified route in the left arm on 30Jan2021 at 12:00 PM, as a first single dose for COVID-19 immunization. The patient got the COVID-19 vaccine administered at the hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced dizziness and hypertension. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with meclizine and increased dose of lisinopril for the adverse events. The clinical outcome of dizziness and hypertension was not recovered. No follow-up attempts are needed. No further information is expected.

I got really sick; Couldn't get out of bed; Dizzy; Throwing up; I was down all day, I couldn't get my head off the pillow; Nauseous; Achy; I have the flu; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received(PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER8737) first dose via an unspecified route of administration on 09Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got vaccine last Friday and she got really sick on 10Apr2021, she had the flu on Apr2021, she couldn't get out of bed on 10Apr2021 i.e., Saturday, she was dizzy on 10Apr2021 and achy on Apr2021, throwing up on 10Apr2021. This is the first one she got and she had to go back on 04May2021 to get the second one but she got really sick with this. she just wanted to let you guys know, it started on Friday and she was down all day, she couldn't get her head off the pillow, nauseous on 10Apr2021. she had the Pfizer one the first dose. The patient got only sick and experienced all of the above on the day after the covid 19 vaccine. It lasted a week on and off. some days she felt good, others not so good. The out come of the events like illness, fatigue, dizziness, vomiting, Nausea were recovered and the outcome of the events like flu, pain was unknown. Follow up(11May2021):This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: The event onset dates updated. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly in right arm on 27Apr2021 at 11:30 (at the age of 62-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included anaphylactic allergies to peanuts and all its products. Concomitant medication included unspecified vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered intramuscularly on 06Apr2021 at 11:30, 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 28Apr2021 at 00:00, the patient felt like there was a 6 to 8-inch-wide rubber band that was too small and tight around her knees, wrists, elbows, ankles, and feet. The patient had a lot of pain in all joint areas, in between each joint there were waves of being extremely achy and there were waves of a tingling feeling, for example like when the foot falls asleep. The patient reported that the pain was so much, and she just laid still in bed the next 20 hours without moving much. On 29Apr2021, the following day after the pain, the patient was just wrenched and exhausted. The patient had a big stuffy and achy in the head area. On 18May2021, at night the patient felt every sensation came back, but not as severe as earlier. The events were reported as non-serious. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Constant pain in the left arm at injection site near shoulder, numbness to wrist. Unable to lift left hand and straighten hand only a few inches above head. Unable to carry weight on left arm. Started 2/5/21 until now, constant pain. Used over the counter pain relievers, ice and heat packs. Lidocaine and capsaicin creams with no relief

PER PT DESCRIPTION:I got the vaccine around 11 am last Friday. Thanks to you, I was calm and relaxed during the vaccination. I was fine and was able to return home safe. However, at around 5 pm, I felt a sudden pain on my right leg. My leg felt hot, became red, and had a big lump or swelling which was about 10 cm. The leg was not just feeling hot but was also hard like board. And I could not move my leg. I was really scared, and was thinking of calling an ambulance. Thankfully, everything went back to normal after 5 minutes - no pain, no swelling, no reddish color, and I was able to move my leg. However, after 30 minutes, the same thing happened to my left leg. But the pain was a little weaker and I could still move it despite the pain. The left one was not so bad compared with right one. And a few minutes after, my left leg was fine. Everything was okay like nothing happened. I did not notice any mark on any of my legs. However, at around 9 pm, I looked at my leg and I noticed a circular trace/mark which was about 10 cm on my right leg. Please see the photo attached.

Within 24 hours fever, chills, loss of appetite/taste and lethargic gradually subsiding over a week. 2nd week after shot - Still no appetite /taste. Lethargy continues (needing multiple naps) and just not feeling well. Severe pain scale of 1-10 (1 being least and 10 being most) at varying from 5-10 (non specific to joint or muscles and including both muscle and bones) Bilaterally across both lower legs . Gradually subsiding in left leg, continuing in Right leg (2 weeks out still a 4 in right leg) . Still not able to walk normal. Still no energy and loss of appetite and smell.